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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines [Mīkstie vāki]

(Principal Consultant and Subject Matter Expert, Grimalkin Partners, Silver Spring, MD; Adjunct Professor, Catholic University of America, USA)
  • Formāts: Paperback / softback, 450 pages, height x width: 235x191 mm, weight: 880 g
  • Izdošanas datums: 01-Dec-2017
  • Izdevniecība: Academic Press Inc
  • ISBN-10: 0128092904
  • ISBN-13: 9780128092903
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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology MedicinesPalielināt
  • Formāts: Paperback / softback, 450 pages, height x width: 235x191 mm, weight: 880 g
  • Izdošanas datums: 01-Dec-2017
  • Izdevniecība: Academic Press Inc
  • ISBN-10: 0128092904
  • ISBN-13: 9780128092903
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780128092903.html
Keywords:

International Regulation of Biologicals serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials and industry scientists working with biologicals.

  • Provides a broad overview and introduction to the regulatory processes from product development pathway through clinical trials and product development stages and beyond
  • Includes FDA, EMA, ICH and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different
  • Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated

Papildus informācija

This book surveys the regulation of biologicals from an international perspective, building upon foundational information and featuring real-world case studies
About the Author xix
Preface xxi
Acknowledgments xxvii
How to Obtain Documents from ICH and US 1(4)
SECTION I REGULATORY PROCESS
Chapter 1 Introduction to the Regulatory Process for Biologicals
5(14)
1.1 Fundamentals
5(10)
1.1.1 Introduction to the Text
5(3)
1.1.2 Regulations
8(2)
1.1.3 Milestones in FDA History
10(4)
1.1.4 European Medicines Agency
14(1)
1.2 Some Details
15(1)
1.2.1 Regulatory Principles
15(1)
1.2.2 Regulatory Affairs vs. Regulatory Science
16(1)
1.3 Case Studies
16(1)
1.4 Conclusions
17(2)
References and Resources
18(1)
Further Reading
18(1)
Chapter 2 Discovery and Development
19(10)
2.1 Fundamentals
19(6)
2.1.1 Introduction
19(1)
2.1.2 Discovery vs. Development
19(2)
2.1.3 Before the Regulatory Process Begins
21(1)
2.1.4 The Regulatory Process
22(2)
2.1.5 Costs and Timeframes to Develop a New Drug
24(1)
2.2 Some Details
25(1)
2.2.1 Focus on Biologicals
25(1)
2.3 Case Studies
26(1)
2.4 Conclusions
27(2)
References and Resources
27(1)
Further Reading
27(2)
Chapter 3 International Regulatory Convergence Rebecca Sheets and Ivana Knezevic
29(12)
3.1 Fundamentals
29(6)
3.1.1 Introduction
29(1)
3.1.2 International Council for Harmonisation (ICH)
29(4)
3.1.3 World Health Organization (WHO)
33(1)
3.1.4 Other Organizations Involved in Regulatory Convergence or Harmonization Efforts
34(1)
3.1.5 Genetically Modified Organisms (GMOs)
35(1)
3.2 Some Details
35(2)
3.2.1 How WHO Develops Guidelines and Recommendations
35(1)
3.2.2 WHO Prequalification
36(1)
3.2.3 Pharmacopeia
37(1)
3.3 Case Studies
37(2)
3.3.1 FDA vs. EMA Approval Times
37(1)
3.3.2 Differing Rotavirus Vaccine Decisions
38(1)
3.4 Conclusions
39(2)
References and Resources
39(2)
Chapter 4 Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial Authorization (AKA PRE-IND)
41(20)
4.1 Fundamentals
41(7)
4.1.1 Introduction
41(1)
4.1.2 Three Types of Things Regulators Need to Know
42(1)
4.1.3 The Pre-IND Process
43(1)
4.1.4 Presubmission Meeting With Other Regulators Including EMA
44(1)
4.1.5 Types of Meetings With U.S. FDA
45(3)
4.2 Some Details
48(5)
4.2.1 Regulatorese
48(2)
4.2.2 Strategies for Meeting Success
50(2)
4.2.3 End-of-Phase-2 Meetings
52(1)
4.3 Case Studies
53(1)
4.4 Summary and Conclusions
53(8)
References and Resources
54(1)
Appendix: An Example of an Assignment Testing One's Ability to Identify Deficiencies in a Pre-IND Meeting Briefing Package and Questions and to Generate Appropriate Advice for a Fictitious Applicant
54(1)
Treatment for Blinker's Disease
54(5)
Bibliography
59(2)
Chapter 5 Clinical Trial Authorization and Investigational New Drug Applications
61(18)
5.1 Fundamentals
61(9)
5.1.1 Introduction
61(1)
5.1.2 The U.S. IND (Investigational New Drug Application)
62(4)
5.1.3 Maintenance of the IND
66(1)
5.1.4 Clinical Holds, Termination, Withdrawal
67(2)
5.1.5 Clinical Trial Authorization, Approval, or Application (CTA)
69(1)
5.1.6 Clinical Trial Notification or Clinical Trial Exemption (Australia)
70(1)
5.2 Some Details
70(2)
5.2.1 Drug or Biologics Master Files
70(2)
5.2.2 Confidentiality of Companies' Proprietary Data
72(1)
5.3 Case Studies
72(4)
5.3.1 Causes of Clinical Holds
72(2)
5.3.2 Niggling Issues for Regulatory Submissions
74(2)
5.4 Conclusions
76(3)
References and Resources
76(1)
Further Reading
77(2)
Chapter 6 Marketing Authorization
79(20)
6.1 Fundamentals
79(13)
6.1.1 Introduction
79(2)
6.1.2 Common Technical Document
81(2)
6.1.3 Labeling, Advertising, and Promotional Labeling
83(2)
6.1.4 Post-Marketing Commitments, Post-Authorisation Measures
85(1)
6.1.5 Post-Marketing Surveillance and Pharmacovigilance
86(1)
6.1.6 License Supplements (Variations) and Annual Reports
87(1)
6.1.7 Review Teams and Managed Review Processes
87(4)
6.1.8 Filing or Refuse-to-File
91(1)
6.1.9 Public Transparency of Scientific Opinion or Licensure Decision
92(1)
6.2 Some Details
92(3)
6.2.1 Recalls or Market Withdrawals
92(1)
6.2.2 License Revocation or Suspension
93(1)
6.2.3 Risk Management Plans or Risk Minimization Action Plans
94(1)
6.2.4 Pharmacovigilance
94(1)
6.3 Case studies
95(1)
6.3.1 Timelines to Approval comparing U.S. FDA and EMA
95(1)
6.3.2 Drug Withdrawals
96(1)
6.4 Conclusions
96(3)
References and Resources
97(2)
Chapter 7 Alternative Regulatory Pathways and Special Programs
99(20)
7.1 Fundamentals
99(12)
7.1.1 Introduction
99(1)
7.1.2 IND Programs
99(5)
7.1.3 BLA and NDA Programs
104(5)
7.1.4 EMA Programs
109(2)
7.2 Some Details
111(2)
7.2.1 Compassionate Use, Expanded Access, Emergency Use, and Accelerated Approval
111(1)
7.2.2 Surrogate Endpoints for Accelerated Approval
112(1)
7.3 Case Studies
113(3)
7.3.1 Opinions
113(2)
7.3.2 PREA
115(1)
7.3.3 Animal Rule
115(1)
7.4 Conclusions
116(3)
References
117(2)
Chapter 8 Variations or Changes to an Approved Application
119(10)
8.1 Fundamentals
119(5)
8.1.1 Introduction
119(1)
8.1.2 Responsibility to Report Changes to An Approved Application
120(1)
8.1.3 Reporting Categories
121(1)
8.1.4 Examples of Changes by Reporting Category
122(1)
8.1.5 EMA Process
123(1)
8.2 Some Details
124(2)
8.2.1 Comparability Protocols
124(2)
8.2.2 Combination Products
126(1)
8.3 Case Studies
126(1)
8.4 Conclusions
127(2)
References and Resources
127(2)
Chapter 9 Audits and Regulatory Compliance Inspections
129(16)
9.1 Fundamentals
129(8)
9.1.1 Introduction
129(1)
9.1.2 U.S. FDA Establishment Inspections
129(3)
9.1.3 Bioresearch Monitoring (BiMo) Inspections
132(1)
9.1.4 Types of Inspections
133(1)
9.1.5 Timing of BiMo Inspections
133(1)
9.1.6 What Happens at an Inspection?
134(1)
9.1.7 Outcomes of Inspections and Warning Letters
135(1)
9.1.8 Official (Legal) Actions
136(1)
9.1.9 Inspections by Other Regulators or Inspectorates
136(1)
9.2 Some Details
137(4)
9.2.1 Audits
137(1)
9.2.2 Compounding Pharmacies
137(1)
9.2.3 Trends in Warning Letters
138(1)
9.2.4 Costumer Complaints
138(1)
9.2.5 Do's and Don'ts in an Inspection or Audit
139(2)
9.3 Case Studies
141(1)
9.4 Conclusions
141(4)
References and Resources
142(1)
Additional Resources
142(1)
Six-Systems Risk-Based Inspection Initiative of USFDA
143(1)
USFDA Inspection Procedures and SOPs
143(2)
Chapter 10 Good "X" Practices
145(26)
10.1 Fundamentals
145(7)
10.1.1 Introduction
145(1)
10.1.2 What are the GXPs and Why Are They Needed?
145(2)
10.1.3 Good Clinical Practices
147(3)
10.1.4 Good Manufacturing Practices
150(1)
10.1.5 Good Laboratory Practices
151(1)
10.1.6 Good Clinical Laboratory Practices
152(1)
10.2 Some Details
152(2)
10.2.1 Electronic Data Capture
152(1)
10.2.2 More on GMP-Compliance for Phase 1
153(1)
10.3 Case Studies
154(2)
10.3.1 Clinical Data Capture in Foreign Trials, Compliance With GCP
154(1)
10.3.2 Preclinical and Manufacturing Compliance With GXP for Phase 1
155(1)
10.4 Conclusions
156(3)
Resources
157(1)
References and Resources
157(2)
Written Assignments Exercise
159(4)
Introduction to the Scenarios
159(1)
Rules About Plagiarism
159(1)
The Assignment and Grading
160(1)
Assignment Questions and Tasks
160(3)
Assignment Scenarios
163(8)
SECTION II REGULATORY SCIENCE
PART I PRECLINICAL
Chapter 11 Preclinical Safety and Toxicology
171(26)
11.1 Fundamentals
171(11)
11.1.1 Introduction
171(3)
11.1.2 Biologicals are Not Drugs, Even Though Technically They are
174(2)
11.1.3 Types of Toxicology Studies
176(1)
11.1.4 Margin-of-Safety
177(2)
11.1.5 Goals of a Preclinical Safety Study
179(1)
11.1.6 Choice of Animal Models
179(1)
11.1.7 Specialized Toxicology/Safety Studies
180(1)
11.1.8 Guidance Documents
181(1)
11.2 Some Details
182(9)
11.2.1 Study Protocols
182(1)
11.2.2 Study Reports
183(1)
11.2.3 Sample Vaccine Toxicology Study
184(2)
11.2.4 Data Evaluation
186(5)
11.3 Case Studies
191(3)
11.3.1 Reconsideration of Using Traditional Drug-Screen Toxicology Methods to Evaluate Vaccines
191(3)
11.4 Conclusions
194(3)
References and Resources
195(1)
Further Reading
196(1)
Chapter 12 Preclinical Pharmacology, Proof-of-Principle
197(12)
12.1 Fundamentals
197(6)
12.1.1 Introduction
197(1)
12.1.2 Animal Welfare Ethics and the 3 R's
197(2)
12.1.3 Pharmacology
199(1)
12.1.4 Vaccine "Pharmacology" and Immunogenicity
200(2)
12.1.5 Mode of Action, Mechanism of Action
202(1)
12.2 Some Details
203(3)
12.2.1 European Directive vs. U.S. Act for 3 R's
203(1)
12.2.2 Challenge Protection Studies
204(1)
12.2.3 Bioassays
205(1)
12.3 Case Studies
206(1)
12.4 Conclusions
207(2)
References and Resources
207(2)
Chapter 13 Institutional Biosafety Committees and Regulation of Genetically Modified Organisms
209(10)
13.1 Fundamentals
209(3)
13.1.1 Introduction
209(1)
13.1.2 GMOs
210(1)
13.1.3 Oversight
210(1)
13.1.4 Biosafety Levels and Biological Containment
211(1)
13.1.5 GMO Regulation in Countries other than the United States
212(1)
13.2 Some Details
212(4)
13.2.1 Human Challenge Trials
212(4)
13.3 Case Studies
216(1)
13.3.1 Retroviral Gene Therapy That Caused Leukemias
216(1)
13.3.2 Tegenero Anti-CD28 Monoclonal Antibody
217(1)
13.3.3 Adenovirus-Vectored Gene Therapy at University of Pennsylvania
217(1)
13.4 Conclusions
217(2)
References and Resources
218(1)
Chapter 14 Risk Assessments
219(14)
14.1 Fundamentals
219(6)
14.1.1 Introduction
219(1)
14.1.2 What Risk Assessment is and is Not
219(1)
14.1.3 Elements of Risk Assessment
220(4)
14.1.4 Criteria for Decision-Making
224(1)
14.1.5 Terminology
225(1)
14.2 Some Details
225(2)
14.2.1 Risk Management
225(1)
14.2.2 Formal Tools for Risk Assessment in Medicinal Product Quality
225(1)
14.2.3 Risk Perception
226(1)
14.2.4 Risk Communication
227(1)
14.3 Case Studies
227(1)
14.3.1 Manufacturing Risk Assessments
227(1)
14.3.2 Risk Management Plan (RMP or RiskMAP)
228(1)
14.4 Conclusions
228(5)
References and Resources
229(1)
Further Reading
229(4)
PART II PRODUCT
Chapter 15 Product Construction, Manufacture, and Process Validation
233(24)
15.1 Fundamentals
233(10)
15.1.1 Introduction
233(3)
15.1.2 Target Product Profile (TPP)
236(1)
15.1.3 The Quality Unit and Documentation
237(1)
15.1.4 Deviations and Investigations
238(1)
15.1.5 Stability
239(1)
15.1.6 Process Validation
239(1)
15.1.7 Viral Safety and Viral Validation
240(3)
15.2 Some Details
243(8)
15.2.1 Quality by Design
243(2)
15.2.2 Cell Line Characterization
245(1)
15.2.3 Product Characterization
246(1)
15.2.4 Quality Agreements
247(2)
15.2.5 Manufacturing Facilities (Establishments, Premises)
249(1)
15.2.6 Reprocessing or Rework
250(1)
15.3 Case Studies
251(2)
15.3.1 Necessity for GMP at Early Stages of Manufacturing
251(1)
15.3.2 Quality by Design Case Studies
252(1)
15.4 Conclusions
253(4)
References and Resources
253(4)
Chapter 16 Lot Release, Analytics, and Analytical Validation
257(22)
16.1 Fundamentals
257(11)
16.1.1 Introduction
257(1)
16.1.2 Definitions (as Terms are Used in Book)
258(1)
16.1.3 Compendial Methods
259(1)
16.1.4 In-Process Controls
260(1)
16.1.5 Batch and Lot Release
260(3)
16.1.6 Stability
263(1)
16.1.7 National Control Laboratories (NCLs)
264(1)
16.1.8 What Needs to be Analyzed by Analytical Methods?
264(1)
16.1.9 How Do We Ensure Valid Assays?
264(2)
16.1.10 Purpose of Analytical Validation
266(1)
16.1.11 Validation Performance Parameters
266(2)
16.2 Some Details
268(4)
16.2.1 Re-testing
268(1)
16.2.2 Reference Standards
268(1)
16.2.3 Validation Protocols and Validation Reports
269(1)
16.2.4 Other Validation Parameters
270(2)
16.3 Case Studies
272(2)
16.3.1 The Lot Met Its Release Criteria, So It's Fine, Right?
272(1)
16.3.2 Validation and the Parallel Line Method
273(1)
16.4 Conclusions
274(5)
References and Resources
274(5)
PART III CLINICAL
Chapter 17 Regulatory Aspects of Clinical Trials
279(38)
17.1 Fundamentals
279(17)
17.1.1 Introduction
279(1)
17.1.2 Label Claims or Claims Within Prescribing Information
279(1)
17.1.3 Clinical (or Therapeutic) Indications
279(2)
17.1.4 Randomized, Controlled Trials
281(1)
17.1.5 Controls
282(2)
17.1.6 Blinding or Masking
284(1)
17.1.7 Clinical Trial Phases
285(3)
17.1.8 Evaluating Safety in a Clinical Trial
288(3)
17.1.9 Activity, Efficacy, Study Designs
291(3)
17.1.10 Introduction to Ethics Committees (ECs) or Institutional Review Boards (IRBs)
294(1)
17.1.11 Data Safety Monitoring Boards, Data Monitoring Committees, Endpoint Adjudication Committees
295(1)
17.2 Some Details
296(13)
17.2.1 Protocols
296(1)
17.2.2 Investigators' Brochure
297(1)
17.2.3 Case Report Forms and Diary Cards
298(1)
17.2.4 Data Auditing, Medical Monitors
299(1)
17.2.5 AE Reporting Requirements
299(1)
17.2.6 Relatedness of AEs
299(1)
17.2.7 Stopping Rules
300(1)
17.2.8 Electronic Submission
301(1)
17.2.9 Noninferiority, Superiority, Two-Sided Equivalence
302(1)
17.2.10 Statistical Plans, Analysis
303(1)
17.2.11 Futility Analyses
304(1)
17.2.12 Adaptive Designs
305(1)
17.2.13 Changing Endpoints After Study is Initiated
305(1)
17.2.14 Clinical Trial Registers
306(1)
17.2.15 Study Reports
307(1)
17.2.16 Special Protocol Assessment (U.S. FDA Program)
308(1)
17.2.17 Complaints, Pharmacovigilance, Adverse Event Reporting by Others than the Applicant
308(1)
17.2.18 Risk Management Plans (RMP) or Risk Minimization Action Plans (RiskMAP)
309(1)
17.3 Case Studies
309(2)
17.3.1 Early Trial Halt for Safety
309(1)
17.3.2 Early Trial Halt for Operational Futility
310(1)
17.3.3 Change in Primary Endpoint and Sample Size After Study Initiation Due to Results From Other Trials and Change in Standard-of-Care
311(1)
17.4 Summary or Conclusions
311(6)
References and Resources
312(3)
Additional Resources
315(1)
Instructions How to Obtain Documents From ICH (Guidelines), U.S. FDA (Regulations), EMA (EudraLex), and WHO (Clinical Trial-Related Issues)
315(2)
Chapter 18 Clinical Trial Ethics, Human Subjects Protections, and the Informed Consent Process
317(18)
18.1 Fundamentals
317(11)
18.1.1 Introduction
317(1)
18.1.2 The Nuremburg Code
318(1)
18.1.3 Declaration of Helsinki
318(1)
18.1.4 The Belmont Report
318(3)
18.1.5 Unethical Research That Led to Setting the U.S. Standards
321(2)
18.1.6 U.S. Federal Regulations
323(1)
18.1.7 Safeguards for Vulnerable Populations
324(1)
18.1.8 Introduction to the Informed Consent Process
324(1)
18.1.9 Elements of Informed Consent
325(3)
18.1.10 Informed Consent Process
328(1)
18.2 Some Details
328(3)
18.2.1 Prospect for Benefit
328(1)
18.2.2 Justification of Placebo Use
329(1)
18.2.3 Standard of Care
329(1)
18.2.4 Certificate of Confidentiality
330(1)
18.2.5 Exceptions to Normal Consent Process
330(1)
18.3 Case Studies
331(2)
18.3.1 Practice Cases
331(2)
18.3.2 Gene Therapy Case
333(1)
18.4 Conclusions
333(2)
References and Resources
333(2)
Chapter 19 Independent Ethics Committees and Institutional Review Boards
335(10)
19.1 Fundamentals
335(4)
19.1.1 Introduction
335(1)
19.1.2 Focus on Independence and Ethics
335(1)
19.1.3 U.S. Common Rule and OHRP
336(1)
19.1.4 Why a Separate Regulatory Process?
336(1)
19.1.5 How Does an IRB Work?
337(1)
19.1.6 Document, Document, Document
337(1)
19.1.7 Order of the Regulatory Processes
338(1)
19.1.8 Roles and Responsibilities of the IRB
338(1)
19.1.9 Review Elements
338(1)
19.1.10 Stipulations
339(1)
19.2 Some Details
339(1)
19.2.1 Centralized IRB Review
339(1)
19.2.2 Categories of Review
340(1)
19.2.3 Federal-Wide Assurance
340(1)
19.3 Case Studies
340(1)
19.4 Conclusions
340(5)
References and Resources
341(1)
Additional Resources
341(4)
SECTION III PRODUCT SPECIFIC
Chapter 20 Biosimilars
345(14)
Ivana Knezevic
Rebecca Sheets
20.1 Fundamentals
345(8)
20.1.1 Introduction
345(1)
20.1.2 Similar Biotherapeutic Products (SBP) or Biosimilars
346(6)
20.1.3 Monoclonal Antibody Biosimilars
352(1)
20.2 Some Details
353(2)
20.2.1 Challenges and Opportunities
353(1)
20.2.2 Perspectives on Biosimilars from U.S. FDA, EMA, and Health Canada
354(1)
20.2.3 Interchangeability
355(1)
20.3 Case Studies
355(1)
20.3.1 U.S. FDA Approval of Zarxio
355(1)
20.3.2 Case Studies on Clinical Evaluation of Monoclonal Antibodies as Biosimilars
356(1)
20.3.3 Case Studies on Unwanted Immunogenicity of Monoclonal Antibodies
356(1)
20.4 Conclusions
356(3)
References and Resources
357(2)
Chapter 21 In Vitro Diagnostics and Biotech Medical Devices
359(6)
21.1 Fundamentals
359(4)
21.1.1 Preface
359(1)
21.1.2 Introduction
359(1)
21.1.3 Regulatory Pathways in the United States for Medical Devices
360(1)
21.1.4 What U.S. FDA Reviews
361(1)
21.1.5 Laboratory-Based Tests
362(1)
21.1.6 Companion Diagnostics
362(1)
21.2 Conclusions
363(2)
References and Resources
363(2)
Chapter 22 Regulatory Policy and Public Health Policy
365(10)
22.1 Fundamentals
365(4)
22.1.1 Introduction
365(1)
22.1.2 Examples of Policies
366(1)
22.1.3 Who Makes These Policy Recommendations?
367(1)
22.1.4 Policy Development
368(1)
22.1.5 International Harmonization or Regulatory Convergence
369(1)
22.2 Some Details
369(2)
22.3 Case Studies
371(1)
22.4 Conclusions
371(4)
References and Resources
373(2)
Glossary 375(16)
International Biologicals Regulation: Vaccines, Biotechnology Medicines 391(24)
Rebecca L. Sheets
Index 415
Dr. Rebecca Sheets is currently the Vice President for the International Alliance of Biologicals Standardization, North American affiliate. She is the former Vaccine Scientific and Regulatory Specialist at the National Institute of Allergy and Infectious Diseases. Dr. Sheets served 9 years as a Scientific Reviewer in the Viral Vaccines branch of the Division of Vaccines and Related Products Applications at the Center for Biologics Evaluation and Research at the FDA. From 2006-2014, she served as Co-Chair of the World Health Organizations Study Group on Cell Substrates and as Chair of the Adventitious Agents Sub-committee, as well as authoring several WHO guidelines and publications over the past two decades. She also taught for a decade at the Catholic University of America. Before retirement, she was the Principal Consultant at Grimalkin Partners from 2013-2021.