Atjaunināt sīkdatņu piekrišanu

E-grāmata: Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products

3.82/5 (11 ratings by Goodreads)
(Therapeutic Proteins International, LLC, USA)
  • Formāts: 456 pages
  • Izdošanas datums: 25-Nov-2019
  • Izdevniecība: CRC Press
  • Valoda: eng
  • ISBN-13: 9781351593601
Citas grāmatas par šo tēmu:
  • Formāts - PDF+DRM
  • Cena: 57,60 €*
  • * ši ir gala cena, t.i., netiek piemērotas nekādas papildus atlaides
  • Ielikt grozā
  • Pievienot vēlmju sarakstam
  • Šī e-grāmata paredzēta tikai personīgai lietošanai. E-grāmatas nav iespējams atgriezt un nauda par iegādātajām e-grāmatām netiek atmaksāta.
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid ProductsPalielināt
  • Formāts: 456 pages
  • Izdošanas datums: 25-Nov-2019
  • Izdevniecība: CRC Press
  • Valoda: eng
  • ISBN-13: 9781351593601
Citas grāmatas par šo tēmu:

DRM restrictions

  • Kopēšana (kopēt/ievietot):

    nav atļauts

  • Drukāšana:

    nav atļauts

  • Lietošana:

    Digitālo tiesību pārvaldība (Digital Rights Management (DRM))
    Izdevējs ir piegādājis šo grāmatu šifrētā veidā, kas nozīmē, ka jums ir jāinstalē bezmaksas programmatūra, lai to atbloķētu un lasītu. Lai lasītu šo e-grāmatu, jums ir jāizveido Adobe ID. Vairāk informācijas šeit. E-grāmatu var lasīt un lejupielādēt līdz 6 ierīcēm (vienam lietotājam ar vienu un to pašu Adobe ID).

    Nepieciešamā programmatūra
    Lai lasītu šo e-grāmatu mobilajā ierīcē (tālrunī vai planšetdatorā), jums būs jāinstalē šī bezmaksas lietotne: PocketBook Reader (iOS / Android)

    Lai lejupielādētu un lasītu šo e-grāmatu datorā vai Mac datorā, jums ir nepieciešamid Adobe Digital Editions (šī ir bezmaksas lietotne, kas īpaši izstrādāta e-grāmatām. Tā nav tas pats, kas Adobe Reader, kas, iespējams, jau ir jūsu datorā.)

    Jūs nevarat lasīt šo e-grāmatu, izmantojot Amazon Kindle.

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Features:

? Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions

? Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing

? Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements

? Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Preface to the Series-Third Edition xxv
Preface to the Series-Second Edition xxvii
Preface to the Series-First Edition xxxi
Preface to the Volume-First Edition xxxiii
Author xxxv
Part I Regulatory and Manufacturing Guidelines
Chapter 1 U.S. FDA Good Manufacturing Practices
3(30)
I Introduction
3(1)
II U.S. FDA cGMP guidelines
3(20)
A General Provisions
5(24)
Part 210-cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs; General
5(2)
Part 211-cGMP for Finished Pharmaceuticals
7(16)
III Amendments to Part 211
23(2)
IV U.S. FDA cGMP Overview Checklist
25(4)
V Drug Master Files and Certifications
29(1)
A Types of DMFs
29(1)
Glossary
29(4)
Chapter 2 Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use
33(56)
Background
33(1)
Scope of the Guideline
33(1)
General Principles
33(1)
Organization of the Common Technical Document
33(1)
Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
34(4)
Granularity of Document
34(1)
Definition of a Document
34(3)
Document Pagination and Segregation
37(1)
Section Numbering Within Documents
37(1)
Table of Contents Formatting
37(1)
Module 2
37(1)
Module 3
37(1)
Module 4
37(1)
Module 5
38(1)
2.3 Quality Overall Summary
38(2)
Introduction
38(1)
2.3.S Drug Substance (Name, Manufacturer)
38(1)
2.3.S.1 General Information (Name, Manufacturer)
38(1)
2.3.S.2 Manufacture (Name, Manufacturer)
38(1)
2.3.S.3 Characterization (Name, Manufacturer)
38(1)
2.3.S.4 Control of Drug Substance (Name, Manufacturer)
39(1)
2.3.S.5 Reference Standards or Materials (Name, Manufacturer)
39(1)
2.3.S.6 Container Closure System (Name, Manufacturer)
39(1)
2.3.S.7 Stability (Name, Manufacturer)
39(1)
2.3.P v Drug Product (Name, Dosage Form)
39(1)
2.3.P.1 Description and Composition of the Drug Product (Name, Dosage Form)
39(1)
2.3.P.2 Pharmaceutical Development (Name, Dosage Form)
39(1)
2.3.P.3 Manufacture (Name, Dosage Form)
39(1)
2.3.P.4 Control of Excipients (Name, Dosage Form)
39(1)
2.3.P.5 Control of Drug Product (Name, Dosage Form)
39(1)
2.3.P.6 Reference Standards or Materials (Name, Dosage Form)
39(1)
2.3.P.7 Container Closure System (Name, Dosage Form)
40(1)
2.3.P.8 Stability (Name, Dosage Form)
40(1)
2.3.A Appendices
40(1)
2.3.A.1 Facilities and Equipment (Name, Manufacturer)
40(1)
2.3.A.2 Adventitious Agents Safety Evaluation (Name, Dosage Form, Manufacturer)
40(1)
2.3.R Regional Information
40(1)
2.4 Nonclinical Overview
40(1)
General Aspects
40(1)
Content and Structural Format
40(1)
2.5 Clinical Overview
41(3)
2.5.1 Product Development Rationale
42(1)
2.5.2 Overview of Biopharmaceuticals
42(1)
2.5.3 Overview of Clinical Pharmacology
42(1)
2.5.4 Overview of Efficacy
42(1)
2.5.5 Overview of Safety
43(1)
2.5.6 Benefits and Risks Conclusions
44(1)
2.5.7 Literature References
44(1)
2.6 Nonclinical Written and Tabulated Summaries
44(5)
Nonclinical Written Summaries
44(1)
Introduction
44(1)
General Presentation Issues
45(1)
Use of Tables and Figures
45(1)
Length of Nonclinical Written Summaries
45(1)
Sequence of Written Summaries and Tabulated Summaries
45(1)
Content of Nonclinical Written and Tabulated Summaries
45(1)
2.6.1 Introduction
45(1)
2.6.2 Pharmacology Written Summary
45(1)
2.6.2.1 Brief Summary
45(1)
2.6.2.2 Primary Pharmacodynamics
46(1)
2.6.2.3 Secondary Pharmacodynamics
46(1)
2.6.2.4 Safety Pharmacology
46(1)
2.6.2.5 Pharmacodynamic Drug Interactions
46(1)
2.6.2.6 Discussion and Conclusions
46(1)
2.6.2.7 Tables and Figures
46(1)
2.6.3 Pharmacology Tabulated Summary
46(1)
2.6.4 Pharmacokinetics Written Summary
46(1)
2.6.4.1 Brief Summary
46(1)
2.6.4.2 Methods of Analysis
46(1)
2.6.4.3 Absorption
46(1)
2.6.4.4 Distribution
46(1)
2.6.4.5 Metabolism (Interspecies Comparison)
46(1)
2.6.4.6 Excretion
46(1)
2.6.4.7 Pharmacokinetic Drug Interactions
46(1)
2.6.4.8 Other Pharmacokinetic Studies
47(1)
2.6.4.9 Discussion and Conclusions
47(1)
2.6.4.10 Tables and Figures
47(1)
2.6.5 Pharmacokinetics Tabulated Summary
47(1)
2.6.6 Toxicology Written Summary
47(1)
2.6.6.1 Brief Summary
47(1)
2.6.6.2 Single-Dose Toxicity
47(1)
2.6.6.3 Repeat-Dose Toxicity (Including Supportive Toxicokinetics Evaluation)
47(1)
2.6.6.4 Genotoxicity
47(1)
2.6.6.5 Carcinogenicity (Including Supportive Toxicokinetics Evaluations)
47(1)
2.6.6.6 Reproductive and Developmental Toxicity (Including Range-Finding Studies and Supportive Toxicokinetics Evaluations)
47(1)
2.6.6.7 Local Tolerance
48(1)
2.6.6.8 Other Toxicity Studies (If Available)
48(1)
2.6.6.9 Discussion and Conclusions
48(1)
2.6.6.10 Tables and Figures
48(1)
2.6.7 Toxicology Tabulated Summary (See Appendix B)
48(1)
2.7 Clinical Summary
49(11)
2.7.1 Summary of Biopharmaceutical Studies and Associated Analytical Methods
49(1)
2.7.1.1 Background and Overview
49(1)
2.7.1.2 Summary of Results of Individual Studies
49(1)
2.7.1.3 Comparison and Analyses of Results Across Studies
49(1)
2.7.1.4 Appendix
50(1)
2.7.2 Summary of Clinical Pharmacology Studies
50(2)
2.7.2.1 Background and Overview
50(1)
2.7.2.2 Summary of Results of Individual Studies
50(1)
2.7.2.3 Comparison and Analyses of Results Across Studies
50(1)
2.7.2.4 Special Studies
51(1)
2.7.2.5 Appendix
51(1)
2.7.3 Summary of Clinical Efficacy
52(2)
2.7.3.1 Background and Overview of Clinical Efficacy
52(1)
2.7.3.2 Summary of Results of Individual Studies
52(1)
2.7.3.3 Comparison and Analyses of Results across Studies
52(1)
2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
53(1)
2.7.3.5 Persistence of Efficacy and/or Tolerance Effects
54(1)
2.7.3.6 Appendix
54(1)
2.7.4 Summary of Clinical Safety
54(6)
2.7.4.1 Exposure to the Drug
54(1)
2.7.4.2 Adverse Events
55(3)
2.7.4.3 Clinical Laboratory Evaluations
58(1)
2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety
58(1)
2.7.4.5 Safety in Special Groups and Situations
58(1)
2.7.4.6 Postmarketing Data
59(1)
2.7.4.7 Appendix
59(1)
2.7.5 Literature References
59(1)
2.7.6 Synopses of Individual Studies
59(1)
Module 3: Quality
60(7)
Scope of the Guideline
60(1)
3.1 Table of Contents of Module 3
60(1)
3.2 Body of Data
60(7)
3.2.S Drug Substance (Name, Manufacturer)
60(1)
3.2.S.1 General Information (Name, Manufacturer)
60(1)
3.2.S.1.1 Nomenclature (Name, Manufacturer)
60(1)
3.2.S.1.2 Structure (Name, Manufacturer)
60(1)
3.2.S.1.3 General Properties (Name, Manufacturer)
60(1)
3.2.S.2 Manufacture (Name, Manufacturer)
60(1)
3.2.S.2.1 Manufacturer(s) (Name, Manufacturer)
60(1)
3.2.S.2.2 Description of Manufacturing Process and Process Controls (Name, Manufacturer)
60(1)
3.2.S.2.3 Control of Materials (Name, Manufacturer)
61(1)
3.2.S.2.4 Controls of Critical Steps and Intermediates (Name, Manufacturer)
61(1)
3.2.S.2.5 Process Validation and/or Evaluation (Name, Manufacturer)
62(1)
3.2.S.2.6 Manufacturing Process Development (Name, Manufacturer)
62(1)
3.2.S.3 Characterization (Name, Manufacturer)
62(1)
3.2.S.3.1 Elucidation of Structure and Other Characteristics (Name, Manufacturer)
62(1)
3.2.S.3.2 Impurities (Name, Manufacturer)
62(1)
3.2.S.4 Control of Drug Substance (Name, Manufacturer)
62(1)
3.2.S.4.1 Specification (Name, Manufacturer)
62(1)
3.2.S.4.2 Analytical Procedures (Name, Manufacturer)
62(1)
3.2.S.4.3 Validation of Analytical Procedures (Name, Manufacturer)
62(1)
3.2.S.4.4 Batch Analyses (Name, Manufacturer)
63(1)
3.2.S.4.5 Justification of Specification (Name, Manufacturer)
63(1)
3.2.S.5 Reference Standards or Materials (Name, Manufacturer)
63(1)
3.2.S.6 Container Closure System (Name, Manufacturer)
63(1)
3.2.S.7 Stability (Name, Manufacturer)
63(1)
3.2.S.7.1 Stability Summary and Conclusions (Name, Manufacturer)
63(1)
3.2.S.7.2 Postapproval Stability Protocol and Stability Commitment (Name, Manufacturer)
63(1)
3.2.S.7.3 Stability Data (Name, Manufacturer)
63(1)
3.2.P Drug Product (Name, Dosage Form)
63(1)
3.2.P.1 Description and Composition of the Drug Product (Name, Dosage Form)
63(1)
3.2.P.2 Pharmaceutical Development (Name, Dosage Form)
63(1)
3.2.P.2.1 Components of the Drug Product (Name, Dosage Form)
63(1)
3.2.P.2.2 Drug Product (Name, Dosage Form)
64(1)
3.2.P.2.3 Manufacturing Process Development (Name, Dosage Form)
64(1)
3.2.P.2.4 Container Closure System (Name, Dosage form)
64(1)
3.2.P.2.5 Microbiological Attributes (Name, Dosage Form)
64(1)
3.2.P.2.6 Compatibility (Name, Dosage Form)
64(1)
3.2.P.3 Manufacture (Name, Dosage Form)
64(1)
3.2.P.3.1 Manufacturer(s) (Name, Dosage Form)
64(1)
3.2.P.3.2 Batch Formula (Name, Dosage Form)
64(1)
3.2.P.3.3 Description of Manufacturing Process and Process Controls (Name, Dosage Form)
64(1)
3.2.P.3.4 Controls of Critical Steps and Intermediates (Name, Dosage Form)
65(1)
3.2.P.3.5 Process Validation and/or Evaluation (Name, Dosage Form)
65(1)
3.2.P.4 Control of Excipients (Name, Dosage Form)
65(1)
3.2.P.4.1 Specifications (Name, Dosage Form)
65(1)
3.2.P.4.2 Analytical Procedures (Name, Dosage Form)
65(1)
3.2.P.4.3 Validation of Analytical Procedures (Name, Dosage Form)
65(1)
3.2.P.4.4 Justification of Specifications (Name, Dosage Form)
65(1)
3.2.P.4.5 Excipients of Human or Animal Origin (Name, Dosage Form)
65(1)
3.2.P.4.6 Novel Excipients (Name, Dosage Form)
65(1)
3.2.P.5 Control of Drug Product (Name, Dosage Form)
65(1)
3.2.P.5.1 Specification(s) (Name, Dosage Form)
65(1)
3.2.P.5.2 Analytical Procedures (Name, Dosage Form)
65(1)
3.2.P.5.3 Validation of Analytical Procedures (Name, Dosage Form)
65(1)
3.2.P.5.4 Batch Analyses (Name, Dosage Form)
65(1)
3.2.P.5.5 Characterization of Impurities (Name, Dosage Form)
65(1)
3.2.P.5.6 Justification of Specification(s) (Name, Dosage Form)
65(1)
3.2.P.6 Reference Standards or Materials (Name, Dosage Form)
65(1)
3.2.P.7 Container Closure System (Name, Dosage Form)
66(1)
3.2.P.8 Stability (Name, Dosage Form)
66(1)
3.2.P.8.1 Stability Summary and Conclusion (Name, Dosage Form)
66(1)
3.2.P.8.2 Postapproval Stability Protocol and Stability Commitment (Name, Dosage Form)
66(1)
3.2.P.8.3 Stability Data (Name, Dosage Form)
66(1)
3.2.A Appendices
66(1)
3.2.A.1 Facilities and Equipment (Name, Manufacturer)
66(1)
3.2.A.2 Adventitious Agents Safety Evaluation (Name, Dosage Form, Manufacturer)
66(1)
3.2.A.3 Excipients
67(1)
3.2.R Regional Information
67(1)
3.3 Literature References
67(1)
Module 4: Nonclinical Study Reports
67(1)
General Principles of Nonclinical Overview and Summaries
67(1)
4.1 Table of Contents of Module 4
67(1)
4.2 Study Reports
67(1)
4.3 Literature References
68(1)
Module 5: Clinical Study Reports
68(21)
5.2 Tabular Listing of All Clinical Studies
68(1)
5.3 Clinical Study Reports
69(2)
5.3.1 Reports of Biopharmaceutical Studies
69(1)
5.3.1.1 Bioavailability (BA) Study Reports
69(1)
5.3.1.2 Comparative BA and BE Study Reports
69(1)
5.3.1.3 In Vitro-In Vivo Correlation Study Reports
69(1)
5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
69(1)
5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials
69(1)
5.3.2.1 Plasma Protein Binding Study Reports
69(1)
5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies
69(1)
5.3.2.3 Reports of Studies Using Other Human Biomaterials
69(1)
5.3.3 Reports of Human PK Studies
69(1)
5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports
70(1)
5.3.3.2 Patient PK and Initial Tolerability Study Reports
70(1)
5.3.3.3 Intrinsic Factor PK Study Reports
70(1)
5.3.3.4 Extrinsic Factor PK Study Reports
70(1)
5.3.3.5 Population PK Study Reports
70(1)
5.3.4 Reports of Human Pharmacodynamic (PD) Studies
70(1)
5.3.4.1 Healthy Subject PD and PK/PD Study Reports
70(1)
5.3.4.2 Patient PD and PK/PD Study Reports
70(1)
5.3.5 Reports of Efficacy and Safety Studies
70(1)
5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
71(1)
5.3.5.2 Study Reports of Uncontrolled Clinical Studies
71(1)
5.3.5.3 Reports of Analyses of Data from More than One Study
71(1)
5.3.5.4 Other Study Reports
71(1)
5.3.6 Reports of PostMarketing Experience
71(1)
5.3.7 Case Report Forms and Individual Patient Listings
71(1)
5.4 Literature References
71(20)
1 General Questions Format or Content?
72(1)
2 Questions Regarding Location Issues
73(2)
3 Associated Information Located in Different Sections
75(1)
3.1 Polymorphism
75(1)
3.2 Particle Size
75(1)
3.3 Impurities
75(1)
3.4 New Location of Quality Information for Investigational Formulations
75(1)
3.5 Where Would the Information Related to Nonviral Adventitious Agents be Placed Within Module 3.2?
75(1)
3.6 Location Issues Questions in Drug Substance: 3.2.S
76(3)
4 Location Issues in Drug Product: 3.2.P
79(5)
5 Location Issues in Appendices: 3.2.A
84(1)
6 Safety
84(1)
7 Efficacy
85(1)
8 ISS/ISE
85(4)
Chapter 3 Process Validation: General Principles and Practices
89(8)
I Introduction
89(1)
II Background
89(1)
III Statutory and Regulatory Requirements for Process Validation
90(1)
IV Recommendations
91(3)
A General Considerations for Process Validation
91(1)
B Specific Stages and Activities of Process Validation in the Product Lifecycle
91(9)
1 Stage 1-Process Design
91(1)
2 Stage 2-Process Qualification
92(2)
3 Stage 3-Continued Process Verification
94(1)
V Concurrent Release of Performance Qualification Batches
94(1)
VI Documentation
95(1)
VII Analytical Methodology
95(1)
Bibliography
95(2)
Chapter 4 Bioequivalence Regulatory Compliance
97(28)
I Background
97(1)
II Regulatory Aspects
98(1)
III Equivalence Documentation for Marketing Authorization
98(2)
IV Therapeutic Classification
100(1)
V Topics Related to Regulatory Compliance
100(3)
A Is a BE Study Required?
100(3)
B Prior Review
103(1)
VI Record Maintenance
103(1)
VII Clarification on Requirements
104(3)
A In which cases is it allowed to use a wider acceptance range for the ratio of Cmax?
104(1)
B When can subjects classified as outliers be excluded from the analysis in be studies?
105(1)
C If one side of the 90% CI of a PK variable for testing BE lies on 0.80 or 1.25, can we conclude that the products are bioequivalent?
105(1)
D In which cases may a nonparametric statistical model be used?
105(1)
E When should metabolite data be used to establish BE?
105(1)
F When using metabolite data to establish BE, may one use the same justification for widening the Cmax acceptance criteria as in the case of the parent compound?
106(1)
G What is a "highly variable drug or drug product"?
106(1)
H What are the conditions for using urinary PK data for BE assessment?
107(1)
I Standardization of BE studies with regard to food intake. how strictly should the guideline be interpreted?
107(1)
J Worldwide considerations
107(1)
VIII Postapproval Changes
107(9)
A NDAs: BA and BE studies
108(1)
B Waivers of in vivo BE studies (Biowaivers): NDAs and aNDAs
108(1)
1 Beaded capsules-lower strength
108(1)
2 Tablets-lower strength
108(1)
C Risk-based BE
108(1)
D Typical examples of complex BE
109(3)
1 Digoxin
109(1)
2 Levothyroxine
110(1)
3 Warfarin sodium
111(1)
4 Albuterol metered-dose inhalers
111(1)
E General PK study design and data handling
112(1)
1 Study conduct
112(1)
2 Sample collection and sampling times
112(1)
3 Subjects with predose plasma concentrations
112(1)
4 Data deletion due to vomiting
112(1)
5 PK information recommended for submission
112(1)
6 BE demonstration measures
112(1)
7 CI values
112(1)
8 Statistical information for AUC0-T, AUC0-°, and Cmax
113(1)
F Measurement indices
113(1)
G Dose selection
113(1)
H Multiple strengths of solid oral dosage forms
113(1)
I Manufacturing of pilot batch ("biobatch")
113(1)
J Dosing by labeled concentration
113(1)
K Single dose vs. multiple dose studies
113(1)
L Guidelines on the design of a single-dose study
114(1)
M Guidelines for multiple-dose study
114(1)
N Fed vs. fasted state
115(1)
O Pharmacological end-point studies
115(1)
P Clinical end-point studies
115(1)
Q Analytical methods
116(1)
Assay consideration
116(7)
R Sampling time considerations
117(1)
S Protein binding
117(1)
T Subject number
117(1)
U Crossover and parallel design considerations
117(1)
V Duration of washout time for crossover study
118(1)
W Fed BE studies
118(1)
X Food effects on drug products
118(1)
Y Recommendations for immediate-release drugs:
119(1)
Z Recommendations for modified-release products
119(1)
1 Study design
119(1)
2 General design
119(1)
3 Subject selection
119(1)
4 Dosage strength
119(1)
5 Test meal
120(1)
6 Administration
120(1)
7 Sample collection
120(1)
8 Data analysis and labeling
120(1)
Parent drug vs. metabolites
120(1)
Enantiomers vs. racemates
121(1)
Drug products with complex mixtures as the active ingredients
121(1)
Long half-life drugs
121(1)
First-point Cmax
121(1)
Orally administered drugs intended for local action
121(1)
Sprinkles
122(1)
Special vehicles
122(1)
Locally acting GI drugs
122(1)
Animal drug BE testing
122(1)
Reference product
123(1)
Reference
123(2)
Chapter 5 Bioequivalence Regulatory Review Process and Audit
125(20)
Background
125(1)
Protocols
125(1)
Productivity Documentation
125(8)
Methods Validation for Abbreviated New Drug Applications
126(1)
Good Laboratory Practices
127(1)
Types of Inspections
127(1)
Inspections
127(6)
FDA Audit Plans
133(1)
Part I-Background
133(1)
Part II-Implementation
133(1)
Objective
133(1)
Program Management Instructions
133(1)
Part III-Inspectional
134(1)
Operations
134(1)
Part IV-Analytical
135(1)
Part V-Regulatory/Administrative Strategy
135(1)
Clinical Testing
135(1)
Analytical Testing
135(1)
Bioequivalence Inspection Report
135(5)
Part I-Facilities and Procedures (Clinical and Analytical)
135(1)
Electronic Records and Signatures
136(1)
Clinical Data and Operations
137(5)
General
137(1)
Inspection Procedures
137(1)
Study Responsibility and Administration
137(1)
Protocol
137(1)
Subjects' Records
138(1)
Other Study Records
138(1)
Consent of Human Subjects
138(1)
Institutional Review Board
138(1)
Sponsor
138(1)
Test Article Accountability
139(1)
Records Retention
139(1)
Abbreviated Report Format
139(1)
Analytical Data and Operations
140(2)
Bibliography
142(3)
Chapter 6 EU Guidelines to Good Manufacturing Practice: Active Drug Substance
145(24)
1.1 Objective
145(1)
1.2 Scope
145(1)
2 Quality Management
146(1)
2.1 Principles
146(1)
2.2 Responsibilities of the Quality Unit(s)
147(1)
2.3 Responsibility for Production Activities
147(1)
2.4 Internal Audits (Self-Inspection)
147(1)
3 Personnel
147(1)
3.1 Personnel Qualifications
147(1)
3.2 Consultants
148(1)
4 Buildings and Facilities
148(1)
4.1 Design and Construction
148(1)
4.2 Utilities
148(1)
4.3 Water
149(1)
4.4 Containment
149(1)
4.5 Lighting
149(1)
4.6 Sewage and Refuse
149(1)
4.7 Sanitation and Maintenance
149(1)
5 Process Equipment
149(2)
5.1 Design and Construction
149(1)
5.2 Equipment Maintenance and Cleaning
150(1)
5.3 Calibration
150(1)
5.4 Computerized Systems
150(1)
6 Documentation and Records
151(2)
6.1 Documentation System and Specifications
151(1)
6.2 Equipment Cleaning and Use Record
151(1)
6.3 Records of Raw Materials, Intermediates, API Labeling, and Packaging Materials
151(1)
6.4 Master Production Instructions (Master Production and Control Records)
151(1)
6.5 Batch Production Records (Batch Production and Control Records)
152(1)
6.6 Laboratory Control Records
152(1)
6.7 Batch Production Record Review
153(1)
7 Materials Management
153(1)
7.1 General Controls
153(1)
7.2 Receipt and Quarantine
153(1)
7.3 Sampling and Testing of Incoming Production Materials
153(1)
7.4 Storage
154(1)
7.5 Reevaluation
154(1)
8 Production and In-Process Controls
154(1)
8.1 Production Operations
154(1)
8.2 Time Limits
154(1)
8.3 In-Process Sampling and Controls
154(1)
8.4 Blending Batches of Intermediates or APIs
155(1)
8.5 Contamination Control
155(1)
9 Packaging and Identification Labeling of APIs and Intermediates
155(1)
9.1 General
155(1)
9.2 Packaging Materials
155(1)
9.3 Label Issuance and Control
155(1)
9.4 Packaging and Labeling Operations
156(1)
10 Storage and Distribution
156(1)
10.1 Warehousing Procedures
156(1)
10.2 Distribution Procedures
156(1)
11 Laboratory Controls
156(2)
11.1 General Controls
156(1)
11.2 Testing of Intermediates and APIs
157(1)
11.3 Validation of Analytical Procedures
157(1)
11.4 Certificates of Analysis
157(1)
11.5 Stability Monitoring of APIs
157(1)
11.6 Expiry and Retest Dating
158(1)
11.7 Reserve/Retention Samples
158(1)
12 Validation
158(2)
12.1 Validation Policy
158(1)
12.2 Validation Documentation
158(1)
12.3 Qualification
158(1)
12.4 Approaches to Process Validation
159(1)
12.5 Process Validation Program
159(1)
12.6 Periodic Review of Validated Systems
159(1)
12.7 Cleaning Validation
159(1)
12.8 Validation of Analytical Methods
160(1)
13 Change Control
160(1)
14 Rejection and Reuse of Materials
160(1)
14.1 Rejection
160(1)
14.2 Reprocessing
160(1)
14.3 Reworking
161(1)
14.4 Recovery of Materials and Solvents
161(1)
14.5 Returns
161(1)
15 Complaints and Recalls
161(1)
16 Contract Manufacturers (including Laboratories)
161(1)
17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
162(1)
17.1 Applicability
162(1)
17.2 Quality Management
162(1)
17.3 Repackaging, Relabeling, and Holding of APIs and Intermediates
162(1)
17.4 Stability
162(1)
17.5 Transfer of Information
162(1)
17.6 Handling of Returns
163(1)
18 General
163(1)
18.1 Cell Bank Maintenance and Record Keeping
163(1)
18.2 Cell Culture/Fermentation
164(1)
18.3 Harvesting, Isolation, and Purification
164(1)
18.4 Viral Removal/Inactivation steps
164(1)
19 APIs for Use in Clinical Trials
164(1)
19.1 General
164(1)
19.2 Quality
164(1)
19.3 Equipment and Facilities
165(1)
19.4 Control of Raw Materials
165(1)
19.5 Production
165(1)
19.6 Validation
165(1)
19.7 Changes
165(1)
19.8 Laboratory Controls
165(1)
19.9 Documentation
165(1)
Glossary
165(4)
Chapter 7 FDA Pre-approval Inspections
169(20)
I Introduction
169(3)
A Background
169(1)
B Objective
169(2)
C Triggering of Inspections
171(1)
D Inspections/Audits
171(1)
1 Manufacturing Process
171(1)
2 Reprocessing
171(1)
3 Laboratory
172(1)
4 Components
172(1)
5 Building and Facilities
172(1)
6 Equipment
172(1)
7 Packaging and Labeling Controls
172(1)
II Regulatory/Administrative Strategy
172(10)
A General
172(1)
B Process Validation
172(1)
C Key Elements
173(1)
D Strategies for Pre-Inspection
173(1)
E International Inspection
173(4)
F Product Stability Data
177(2)
G Validation of Processes
179(2)
H Change Control
181(1)
1 Cleaning Validation
181(1)
2 Analytical Methods Validation
181(1)
3 Computer System Validation
182(1)
Part 11-Electronic Records; Electronic Signatures
182(3)
Subpart A-General Provisions
182(1)
Sec.11.1 Scope
182(1)
Sec.11.2 Implementation
182(1)
Sec.11.3 Definitions
183(1)
Subpart B-Electronic Records
183(1)
Sec.11.10 Controls for closed systems
183(1)
Sec.11.30 Controls for open systems.
184(1)
Sec.11.50 Signature manifestations
184(1)
Sec.11.70 Signature/record linking.
184(1)
Subpart C-Electronic Signatures
184(1)
Sec.11.100 General requirements
184(1)
Sec.11.200 Electronic signature components and controls.
184(1)
Sec.11.300 Controls for identification codes/passwords
184(1)
Documentation Standards
185(4)
1 Development History Report
186(1)
2 Deviation Records
186(1)
3 Installation, Operational, and Performance Qualification
186(1)
4 Organizational Chart
186(1)
5 Products List
186(1)
6 Drawings
187(1)
7 Stability Data
187(1)
8 SOPS
187(1)
9 Training Records
187(1)
10 Validation Records
187(1)
11 Technology Transfer and Scale-Up
187(1)
12 Quality Policy
187(1)
13 Vendor Approval
188(1)
14 Outside Contractors
188(1)
Chapter 8 Formulation Factors in Uncompressed Dosage Forms
189(8)
Introduction
189(1)
Capsules
189(2)
Manufacture of Hard Gelatin Shells
189(1)
Hard-Gelatin Capsule Filling
190(1)
Oral Powders
191(1)
Nasal Powders
191(2)
Formulation and Manufacturing Considerations
193(3)
Relative Humidity
193(1)
Surface Area
193(1)
Sieve Analysis
193(1)
Particle Size Distribution
194(1)
Powder Flow Properties
194(1)
Real, Tapped, and Bulk Density
194(1)
Mixing
195(1)
Mixing Mechanisms
195(1)
Segregation Mechanisms
195(1)
Mixing Equipment
195(1)
Milling
196(1)
Powder Handling
196(1)
References
196(1)
Chapter 9 Solid-State Properties
197(30)
1 Introduction
197(1)
2 Crystal Morphology
197(4)
3 Polymorphism
201(3)
4 High-Throughput Crystal Screening
204(1)
5 Solvates
205(1)
Hydrates
205(1)
6 Amorphous Forms
206(1)
7 Hygroscopicity
206(1)
8 Solubility
207(3)
8.1 Salt Form
207(2)
8.2 Melting Point
209(1)
8.3 Dissolution
209(1)
9 Study Methods
210(7)
Thermal Analysis
210(1)
9.1 Differential Scanning Calorimetry
210(1)
9.2 Hot-Stage Microscopy
211(1)
9.3 Thermogravimetric Analysis
211(1)
9.4 Solution Calorimetry
211(1)
9.5 Isothermal Microcalorimetry
212(1)
9.6 Infrared Spectroscopy
212(1)
9.7 X-Ray Powder Diffraction
213(2)
9.8 Phase Solubility Analysis
215(1)
9.9 Dynamic Vapor Sorption
215(1)
9.10 Dissolution Testing
216(1)
9.11 High-Performance Liquid Chromatography
217(1)
Web References
217(1)
Reading Recommendations
217(10)
Chapter 10 Formulation of Flavor
227(82)
1 Introduction
227(1)
2 Taste-Concealing Goals
227(1)
3 Fluid Bed Coating
227(5)
3.1 Filmcoat Parameters
228(1)
3.2 Filmcoat Formulations
229(2)
3.3 Other Considerations
231(1)
4 Spray Drying or Spray Congealing
232(1)
5 Coacervation
232(1)
6 Inclusion Complexes
232(1)
7 Ion Resin Technology
232(1)
8 Taste Conceal Performance Specifications
233(2)
Appendix A
235(20)
Appendix B
255(26)
Appendix C
281(28)
Part II Manufacturing Formulations
Uncompressed Solids Formulations
309
Acebutolol Hydrochloride Capsules
309(1)
Aceclofenac Instant Granules
309(1)
Acetaminophen and Diphenhydramine Hydrochloride Hot Therapy Sachets
309(1)
Acetaminophen Capsules (500 mg)
309(1)
Acetaminophen, Doxylamine, and Caffeine Effervescent
309(1)
Acetaminophen Instant Granules
310(1)
Acetaminophen Instant Granules
310(1)
Acetaminophen Instant Granules
310(1)
Acetaminophen, Pseudoephedrine Hydrochloride, Chlorpheniramine Hot Therapy Sachet
310(1)
Acetaminophen, Pseudoephedrine Hydrochloride Hot Therapy Sachet
311(1)
Acetaminophen Swallow Capsules
311(1)
Acetazolamide Sustained-Release Capsules
311(1)
Acetylcysteine Sachets
311(1)
Acitretin Capsules
312(1)
Acrivastine and Pseudoephedrine Hydrochloride Capsules
312(1)
Acrivastine and Pseudoephedrine Hydrochloride Capsules
312(1)
Acyclovir Capsules
312(1)
Acyclovir Capsules
312(1)
Adenosine Monophosphate Topical Powder
313(1)
Aluminum Acetate Powder
313(1)
Aluminum Hydroxide and Magnesium Carbonate Dry Syrup
313(1)
Aminosalicylic Acid Granules
313(1)
Amlodipine Besylate and Benazepril Hydrochloride Capsules
313(1)
Amlodipine Besylate and Benazepril Hydrochloride Capsules
313(1)
Amlodipine Besylate Capsules
314(1)
Amlodipine Free Base Capsules
314(1)
Amlodipine Maleate Capsules
314(1)
Amoxicillin and Bromhexine Hydrochloride Capsules
315(1)
Amoxicillin and Clavulanic Acid Powder for Suspension, 125 mg and 31.25 mg per 5 mL (Amoxil)
315(1)
Amoxicillin and Clavulanic Acid Powder for Suspension
315(1)
Amoxicillin and Clavulanate Potassium for Suspension
315(1)
Amoxicillin and Clavulanate Potassium for Suspension
315(1)
Amoxicillin Powder for Suspension (125 and 250 mg)
316(1)
Amoxicillin Trihydrate Capsules (250 and 500 mg)
316(1)
Ampicillin Dry Syrup (5% = 500 mg/10 mL)
316(1)
Ampicillin Powder for Suspension
316(1)
Ampicillin Trihydrate Capsules
317(1)
Ampicillin Trihydrate Capsules for Suspension
317(1)
Ampicillin Trihydrate Powder for Suspension
317(1)
Antibacterial and Bacterial Culture Capsules
318(1)
Antifungal Foot Powder
318(1)
Antioxidant Eye Nutrition Supplement Capsules
319(1)
Aspartame Granules in Sachets
319(1)
Aspartame Powder in Sachets
319(1)
Aspirin and Chlorpheniramine Powder
319(1)
Aspirin-Coated Crystals
319(1)
Aspirin and Phenylpropanolamine Powder
320(1)
Aspirin Microencapsulated Sustained-Release Capsules
320(1)
Aspirin, Salicylamide, and Caffeine Powder
320(1)
Azithromycin Suspension
320(1)
Azithromycin Capsules
320(1)
Azithromycin Capsules
321(1)
Azithromycin Capsules
321(1)
Azithromycin Capsules and Oral Suspension
321(1)
Azithromycin for Oral Suspension
321(1)
Azithromycin for Oral Suspension
322(1)
Azithromycin Sachets for Oral Suspension
322(1)
Balsalazide Disodium Capsules
322(1)
Benazepril Hydrochloride and Amlodipine Besylate Capsules
322(1)
Benazepril Hydrochloride and Amlodipine Besylate Capsules
322(1)
Bisacodyl Colonic Delivery Capsules
323(1)
Brompheniramine and Pseudoephedrine Capsules
323(1)
Budesonide Capsules
324(1)
Budesonide Inhalation Powder
324(1)
Butalbital and Acetaminophen Capsules
324(1)
Calcitonin (Salmon) Capsules
324(1)
Calcitriol Capsules
325(1)
Calcium Carbonate Microencapsulated Sustained-Release Capsules
325(1)
Camptothecin Capsules
325(1)
Carbamazepine Extended-Release Capsules
326(1)
Cefaclor Capsules
326(1)
Cefdinir Capsules and Oral Suspension
326(1)
Cefixime for Oral Suspension
326(1)
Cefpodoxime Proxetil for Oral Suspension
327(1)
Cefprozil for Oral Suspension
327(1)
Ceftibuten Capsules and Oral Suspension
327(1)
Ceftibuten for Oral Suspension
327(1)
Cefuroxime for Oral Suspension
327(1)
Celecoxib Capsules
327(1)
Celecoxib Tablets Celebrex
328(1)
Cellulose Triacetate Liquefiable Topical Powder
328(1)
Cephalexin Capsules
328(1)
Cephalexin Powder for Oral Suspension
328(1)
Cephradine Capsules
329(1)
Cephradine Powder for Suspension
329(1)
Cevimeline Capsules
329(1)
Cevimeline Capsules
329(1)
Chlordiazepoxide Hydrochloride Capsules
329(1)
Chlordiazepoxide Hydrochloride Capsules
330(1)
Chloroxylenol and Chlorhexidine Topical Powder
330(1)
Chlorpromazine Sustained-Release Capsules
330(1)
Cimetidine Microencapsulated Sustained-Release Capsules
330(1)
Citrate Effervescent Powder
330(1)
Clindamycin Capsules
331(1)
Clindamycin Capsules (150 mg)
331(1)
Clofibrate Capsules
331(1)
Clonidine Sustained-Release Capsules
331(1)
Clorazepate Dipotassium Capsules
331(1)
Coated Spheroids
332(1)
Crospovidone Water-Dispersible Tablets
333(1)
Cyanocobalamin Tablets
333(1)
Cyclosporin A Capsules
333(1)
Dantrolene Sodium Capsules
333(1)
Dextroamphetamine Sulfate Capsules
333(1)
Diclofenac and Misoprostol Capsules
333(1)
Diclofenac Spheronized Pellets for Sustained-Release Coating (30%)
334(1)
Diclofenac Sustained-Release Capsules
334(1)
Diclofenac Granules
334(1)
Didanosine Delayed-Release Capsules
335(1)
Didanosine Delayed-Release Capsules Enteric-Coated Beadlets
335(1)
Didanosine for Oral Suspension
335(1)
Diethyl Toluamide Topical Powder
335(1)
Difluoromethylornithine-Alpha Capsules
336(1)
Diltiazem Hydrochloride Extended-Release Capsules
337(1)
Diphenhydramine Hydrochloride Capsules
338(1)
Dipyridamole and Aspirin Extended-Release Capsules
338(1)
Divalproex Sodium Capsules
338(1)
Divalproex Sodium Coated Particle Capsules
338(1)
Dofetilide Capsules
338(1)
Doxepin Hydrochloride Capsules
338(1)
Doxycycline Capsules
339(1)
Doxycycline Hyclate Capsules
339(1)
Doxycycline Hyclate Capsules
339(1)
Doxycycline Hydrochloride Capsules and Oral Suspension
339(1)
Efavirenz Capsules
339(1)
Enalapril Maleate Capsules
339(1)
Enalapril Maleate Capsules
339(1)
Eplerenone Capsules
340(1)
Erythromycin and Bromhexine Powder for Suspension
340(1)
Erythromycin and Sulfisoxazole Granules for Suspension
340(1)
Erythromycin Delayed-Release Capsules
341(1)
Erythromycin Delayed-Release Capsules
341(1)
Erythromycin Ethylsuccinate for Oral Suspension
342(1)
Erythromycin Ethylsuccinate for Oral Suspension (200 mg/5 mL)
342(1)
Erythromycin Stearate for Oral Suspension
342(1)
Erythromycin Stearate for Oral Suspension
343(1)
Erythropoietin Capsules
344(1)
Esomeprazole Magnesium Capsules
345(1)
Estramustine Phosphate Capsules
345(1)
Ethosuximide Capsules
345(1)
Etodolac Capsules
345(1)
Felbamate for Oral Suspension
345(1)
Fenofibrate Capsules
345(1)
Fenofibrate Capsules
346(1)
Fexofenadine Hydrochloride Capsules
346(1)
Fexofenadine Hydrochloride Capsules
346(1)
Fluconazole for Oral Suspension
346(1)
Flucytosine Capsules
346(1)
Fluoxetine Capsules
346(1)
Fluoxetine Hydrochloride Capsules
347(1)
Fluoxetine Hydrochloride Instant and Weekly Capsules
347(1)
Flutamide Capsules
347(1)
Fluticasone Propionate and Salmeterol Xinafoate Inhalation Powder
347(1)
Fluvastatin Sodium Capsules
348(1)
Fluvastatin Sodium Capsules
348(1)
Formoterol Fumarate Inhalation Powder
348(1)
Formoterol Fumarate Inhaler Capsules
348(1)
Fosfomycin Tromethamine Sachets
348(1)
Gabapentin Capsules
348(1)
Gabapentin Capsules
348(1)
Ganciclovir Capsules
349(1)
Ganciclovir Capsules
349(1)
Gemfibrozil Capsules
349(1)
Glycoprotein IIa/IIb Capsules
349(1)
Guaifenesin Sustained-Release Capsules
349(1)
Herbal AIDS Treatment Capsules
350(1)
Histidine Capsules
350(1)
Human Growth Hormone Capsules
350(1)
Hydrochlorothiazide and Triamterene Capsules
351(1)
Hydrochlorothiazide Capsules
351(1)
Hydroxyzine Pamoate Capsules and Oral Suspension
351(1)
Hyoscyamine Sulfate Capsules
351(1)
Ibuprofen Microencapsulated Sustained-Release Capsules
351(1)
Ibuprofen and Domperidone Maleate Capsules
352(1)
Ibuprofen and Domperidone Maleate Effervescent Granules
352(1)
Ibuprofen Sustained-Release Capsules
352(1)
Ifosfamide Capsules
353(1)
Imatinib Mesylate Capsules
353(1)
Indinavir Sulfate Capsules
353(1)
Indinavir Sulfate Capsules
353(1)
Indomethacin Capsules
353(1)
Indomethacin Capsules
354(1)
Indomethacin Capsules
354(1)
Indomethacin Capsules (25 mg)
355(1)
Indomethacin Capsules (50 mg)
355(1)
Indomethacin Powder for Hard Gelatin Capsules (160 mg)
355(1)
Indomethacin Microencapsulated Sustained-Release Capsules
355(1)
Indomethacin Sustained-Release Capsules
356(1)
Insulin Capsules
356(1)
Iron-Polysaccharide Complex Capsules
357(1)
Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsules
357(1)
Isosorbide Mononitrate Capsules (20 mg)
358(1)
Isradipine Capsules
358(1)
Itraconazole Capsules
358(1)
Itraconazole Capsules
358(1)
Ketoprofen and Misoprostol Capsules
358(1)
Ketoprofen Capsules
359(1)
Lansoprazole Capsules
359(1)
Lansoprazole Delayed-Release Capsules
359(1)
Lincomycin Capsules
359(1)
Linezolid Oral Suspension
359(1)
Lipase, Amylase, and Protease Capsules
360(1)
Lithium Carbonate Capsules
360(1)
Loperamide and Trimebutine Capsules
360(1)
Lopinavir-Ritonavir Capsules
360(1)
Loracarbef Capsules and Oral Suspension
360(1)
Loxapine Succinate Capsules
360(1)
Magaldrate Instant Powder or Dry Syrup
360(1)
Magaldrate Instant Powder or Dry Syrup
360(1)
Magnesium Oxide Capsules
361(1)
Mefenamic Acid Capsules
361(1)
Mesalamine Capsules
361(1)
Mesalamine Colonic Delivery Capsules
361(1)
Methsuximide Capsules
361(1)
Methylphenidate Capsules
361(1)
Methylphenidate Capsules
361(1)
Methylphenidate Immediate- and Extended-Release Capsules
362(1)
Methyltestosterone Capsules
362(1)
Metoclopramide Hydrochloride Sustained-Release Capsules
362(1)
Metyrosine Capsules
363(1)
Miconazole Nitrate Foot and Itch Powder
363(1)
Midodrine Capsules
363(1)
Mineral Powder for Topical Herpes Simplex
364(1)
Minocycline Hydrochloride Capsules
364(1)
Mixed Amphetamine Salt Capsules
364(1)
Mixed Amphetamine Salts Enteric-Release Capsules
364(1)
Morphine Sulfate Capsules
364(1)
Morphine Sulfate Controlled-Release Capsules
365(1)
Morphine Sulfate Sustained-Release Capsules
365(1)
Multivitamin Effervescent Granules
366(1)
Multivitamin Effervescent Granules
366(1)
Multivitamin Instant Granules
366(1)
Multivitamin Instant Granules
367(1)
Mycophenolate Mofetil Capsules and Oral Suspension
367(1)
Nanoparticle Polymer Particle Powders
367(1)
Nelfinavir Mesylate Oral Powder
368(1)
Nelfinavir Mesylate Oral Powder
368(1)
Nilvadipine Capsules
368(1)
Nitrofurantoin Capsules
368(1)
Nitrofurantoin Sustained-Release Capsules
368(1)
Nizatidine Capsules
368(1)
Nizatidine Capsules
369(1)
Nystatin Powder
369(1)
Omeprazole and Piroxicam Capsules
369(1)
Omeprazole Capsules
369(1)
Omeprazole Capsules
370(1)
Omeprazole Delayed-Release Capsules
370(1)
Oral Rehydration Salt (45 mEq)
370(1)
Orlistat Capsules
371(1)
Orlistat Capsules
371(1)
Oseltamivir Phosphate Capsules and Oral Suspension
371(1)
Oxcarbazepine Oral Suspension
371(1)
Oxycodone Hydrochloride and Acetaminophen Capsules
371(1)
Oxytetracycline Hydrochloride Capsules
371(1)
Oxytetracycline Hydrochloride, Sulfamethizole, and Phenazopyridine Hydrochloride Capsules
372(1)
Pancrelipase Capsules
372(1)
Pancrelipase Capsules Enteric-Coated Microspheres
372(1)
Penicillamine Capsules
372(1)
Pentosan Polysulfate Sodium Capsules
372(1)
Pentostatin Capsules
372(1)
pH-Sensitive Coated Spheroids
372(1)
Phenobarbital and Hyoscyamine Sulfate Capsules
373(1)
Phenoxybenzamine Hydrochloride Capsules
373(1)
Phentermine Capsules
373(1)
Phentermine Hydrochloride Capsules
373(1)
Phenytoin Sodium Extended-Release Capsules
373(1)
Piroxicam and Beta-Cyclodextrin Topical Powder
373(1)
Piroxicam Capsules
374(1)
Piroxicam Capsules
374(1)
Piroxicam Capsules
374(1)
Polyethylene Glycol 3350 Powder for Reconstitution
374(1)
Polythiazide Capsules
374(1)
Potassium Chloride Extended-Release Capsules
374(1)
Potassium Chloride for Oral Solution
375(1)
Potassium Chloride Microencapsulated Sustained-Release Capsules
375(1)
Potassium Chloride Powder (20 mEq)
375(1)
Prazosin and Polythiazide Capsules
375(1)
Prednisolone Targeted-Release Capsules
376(1)
Procarbazine Hydrochloride Capsules
376(1)
Prochlorperazine Sustained-Release Capsules
376(1)
Propoxyphene Hydrochloride, Caffeine, and Aspirin Capsules
376(1)
Propoxyphene Hydrochloride Capsules
376(1)
Propranolol Hydrochloride and Hydrochlorothiazide Capsules
376(1)
Propranolol Hydrochloride Long-Acting Capsules
376(1)
Propranolol Hydrochloride Multiple Bead Capsules
376(1)
Propranolol Hydrochloride Sustained-Release Capsules
377(1)
Propranolol Timed- and Sustained-Release Capsules
377(1)
Proton Pump Inhibitor Powder for Reconstitution for Oral Use
378(1)
Proton Pump Inhibitor Powder for Reconstitution for Oral Use
378(1)
Pseudoephedrine Hydrochloride Capsules
378(1)
Pseudoephedrine Hydrochloride Capsules
378(1)
Pseudoephedrine and Guaifenesin Capsules
378(1)
Pseudoephedrine Hydrochloride Capsules
378(1)
Psyllium and Dioctyl Sodium Sulfosuccinate Powder
379(1)
Psyllium and Docusate Sodium Wafer
379(1)
Psyllium Husk Granules
379(1)
Ranitidine Effervescent Granules
380(1)
Ribavirin Capsules
380(1)
Rifabutin Capsules
380(1)
Rifampicin Capsules
380(1)
Rifampin and Isoniazid Capsules
380(1)
Rivastigmine Tartrate Capsules
380(1)
Salmeterol Xinafoate Capsules
380(1)
Salmeterol Xinafoate Inhalation Powder
380(1)
Salmeterol Xinafoate Inhalation Powder
380(1)
Saquinavir Mesylate Capsules
380(1)
Selegiline Hydrochloride
381(1)
Sevelamer Hydrochloride Capsules
381(1)
Sibutramine Hydrochloride Capsules
381(1)
Sibutramine Hydrochloride Capsules
381(1)
Simethicone Instant Granules (60 mg and 120 mg)
381(1)
Stavudine Capsules
381(1)
Succimer Capsules
381(1)
Sucralafate Granules
381(1)
Sulfamethoxazole + Trimethoprim Dry Syrup (400 mg + 80 g/10 mL)
382(1)
Tacrine Hydrochloride Capsules
382(1)
Tacrolimus Capsules
382(1)
Tacrolimus Capsules
382(1)
Talc, Crospovidone, and Starch Topical Powder
382(1)
Tamsulosin Hydrochloride Capsules
382(1)
Tamsulosin Hydrochloride Capsules
382(1)
Temazepam Capsules
383(1)
Temozolomide Capsules
383(1)
Terazosin Capsules (1-10 mg) Hytrin
383(1)
Terazosin Capsules
383(1)
Terazosin Hydrochloride Capsules
383(1)
Terfenadine Oral Granules
383(1)
Tetracycline Hydrochloride Capsules
384(1)
Thalidomide Capsules
384(1)
Theophylline Sustained-Release Capsules
384(1)
Thiothixene Capsules
384(1)
Tibolone Capsules
384(1)
Tiotropium Inhalation Powder
385(1)
Tolmetin Sodium Capsules
385(1)
Tolterodine Capsules
385(1)
Tolterodine Capsules
385(1)
Topiramate Capsules
385(1)
Tretinoin Capsules
386(1)
Triamterene and Hydrochlorothiazide Capsules
386(1)
Triamterene Capsules
386(1)
Triclosan and Zinc Foot Deodorant Powder
386(1)
Triclosan and Zinc Undecylenate Powder
386(1)
Trientine Hydrochloride Capsules
387(1)
Trimebutine Capsules
387(1)
Trimethoprim and Sulfamethoxazole Oral Suspension
387(1)
Trimipramine Maleate Capsules
387(1)
Troleandomycin Capsules
387(1)
Typhoid Vaccine Live Oral Capsules
387(1)
Valsartan and Hydrochlorothiazide Capsules
387(1)
Valsartan Capsules
388(1)
Valsartan Capsules
388(1)
Vancomycin Hydrochloride Capsules
388(1)
Venlafaxine Capsules
388(1)
Verapamil Hydrochloride Capsules
388(1)
Verapamil Hydrochloride Capsules
389(1)
Verapamil Hydrochloride Sustained-Release Capsules
389(1)
Vincamine Capsules
389(1)
Vinpocetine Multiple Bead Capsules
390(1)
Vitamin B Complex, Amino Acids, and Magnesium Effervescent Granules (Sugar-Free)
390(1)
Vitamin B Complex + Amino Acid + Magnesium Effervescent Granules (Sugar-free)
390(1)
Vitamin B Complex and Vitamin C Instant Granules
390(1)
Vitamin C and Calcium Carbonate Effervescent Powder
391(1)
Zanamivir Powder
391(1)
Zanamivir Powder
391(1)
Zidovudine Capsules
391(1)
Zidovudine Capsules
391(1)
Zinc Oxide and Cornstarch Powder
391(1)
Ziprasidone Hydrochloride Capsules
391(1)
Ziprasidone Hydrochloride Capsules
392(1)
Zonisamide Capsules
392(1)
Zonisamide Capsules
392
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations 395(14)
Index 409
Sarfaraz K. Niazi, Ph.D., a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines. He is Founder and Executive Chairman of Adello Biologics, LLC, (formerly, Therapeutic Proteins International, LLC), a biosimilar products company located in Chicago, IL, Piscataway, NJ and Cashel, Ireland. As an entrepreneur, Niazi has raised hundreds of millions of dollars and became recognized as an inductee into the Chicago Entrepreneur Hall of Fame.Niazi began his career teaching pharmaceutical sciences at the University of Illinois, College of Pharmacy where he was tenured before entering the industry at Abbott International. He departed Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through the founding a biosimilar products company.

A prolific inventor with scores of patents, most prominently in the field of bioprocessing technology, Niazi is currently the largest single holder of bioprocess technology patents. His other inventions span a broad category of technologies, new chemical entities, new formulations, new analytical methodologies, and much more. He has hands on experience in developing chemical, botanical and biological products, from discovery to regulatory approval. With over 50 ISBNs under his name, Niazi has authored many landmark books in the field of pharmaceutical sciences.

He currently serves as Adjunct Professor at the University of Illinois College of Pharmacy, Ad Hoc faculty at the University of Houston, Texas, the HEJ Research Institute, Karachi, and the National University of Science and Technology, Islamabad. He has also served as a Foreign Professor at the HEJ Research Institute, Karachi. He serves on the editorial board of the journal MOJ Proteomics & Bioinformatics (MOJPB) and starting 2017, as Chief Editor of International Journal of Biosimilars. He also serves as Member of National Advisory Board of the College of Pharmacy, University of Illinois. He is a Fellow of the Pakistan Academy of Medical Sciences, Fellow National Academy of Clinical Biochemistry and Institute of Biology. He served as a TOKTEN Fellow to India (Transfer of Knowledge Through Expatriate Nationals (UNDP). In 2013, he received the one of the highest civilian awards, Star of Distinction in Engineering, from the Pakistani President. He has hosted a radio show at Voice of America (US State Department) on a weekly basis for more than 5 years with audience into billions.
Biežāk uzdotie jautājumi par e-grāmatām Biežāk uzdotie jautājumi par e-grāmatām
Permanent link: https://www.kriso.lv/db/97813515936012e.html
Keywords: