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E-grāmata: Handbook of Modern Pharmaceutical Analysis

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Edited by Stephen Scypinski (R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey, U.S.A.), Edited by Satinder Ahuja (President, Ahuja Consulting for Water Quality, Calabash, NC, USA)

Formāts: PDF+DRM
Sērija : Separation Science and Technology
Izdošanas datums: 11-Nov-2010
Izdevniecība: Academic Press Inc
Valoda: eng
ISBN-13: 9780123759818

Citas grāmatas par šo tēmu:

Pharmacology

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Formāts: PDF+DRM
Sērija : Separation Science and Technology
Izdošanas datums: 11-Nov-2010
Izdevniecība: Academic Press Inc
Valoda: eng
ISBN-13: 9780123759818

Citas grāmatas par šo tēmu:

Pharmacology

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Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use.

*Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it.
*Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations.
*Features detailed coverage of QA, ethics, and regulatory guidance and structures, as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS.

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use.

Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it
Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations
Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Papildus informācija

Authoritative and practical guide to all aspects of modern pharmaceutical analysis

Preface

Contributors

xiii

1 Overview of Modern Pharmaceutical Analysis

Satinder Ahuja

I Introduction

(2)

II Solid-State Studies

(1)

III Degradation and Impurities Studies

(1)

IV Analytical Considerations for Genotoxic and Other Impurities

(1)

V Quality by Design and Process Analytical Technology

(1)

VI Novel Dosage Forms

(1)

VII Method Development for Chiral Compounds

(1)

VIII Characterization and Analysis of Biopharmaceutical Proteins

(1)

IX Preformulation and Early Phase Method Development

(1)

X In-Process Control Testing

(1)

XI Method Validation

(1)

XII Stability Studies

(1)

XIII Method Transfer

(1)

XIV Documentation

(3)

References

(2)

2 Characterization of Pharmaceutical Compounds in the Solid State

Harry G. Brittain

I Introduction

(2)

II Properties Associated with the Molecular Level

(13)

III Properties Associated with the Particulate Level

(10)

IV Properties Associated with the Bulk Level

(13)

V Summary and Conclusions

(11)

References

(11)

3 Degradation and Impurity Analysis for Pharmaceutical Drug Candidates

Karen M. Alsante

Steven W. Baertschi

Michael Coutant

Brian L. Marquez

Thomas R. Sharp

Todd C. Zelesky

I Forced Degradation Studies

(20)

II Isolation of Impurities/Degradants

(20)

III Mass Spectrometry in the Identification of Impurities

100

(26)

IV NMR

126

(21)

V Case Studies

147

(10)

VI Summary

157

(14)

References

158

(13)

4 Analytical Considerations for Genotoxic and Other Impurities

Rodney L. Parsons

Scott A. Miller

I Introduction

171

(1)

II Concept of GTI Relative to Standard Impurities and the Current Regulatory Thinking

172

(1)

III Viracept® GTI Contamination Issue

173

(1)

IV GTI Risk Assessment and Control Strategy Design

174

(5)

V Analytical Challenges

179

(12)

VI Summary and Conclusions

191

(4)

References

191

(4)

5 Quality by Design and the Importance of PAT in QbD

Robert W. Bondi, Jr.

James K. Drennen, III

I Introduction

195

(5)

II The Role of PAT in QbD

200

(21)

III Summary and Considerations Regarding Return on Investment for QbD/PAT

221

(4)

References

222

(3)

6 Novel Dosage Form Analysis

Joseph Etse

I Introduction

225

(2)

II Tablets

227

(10)

III Capsule Dosage Forms

237

(3)

IV Cachet Dosage Forms

240

(1)

V Sustained Release Dosage Forms

241

(3)

VI Solution, Suspension, Emulsion, and Parenteral Dosage Forms

244

(1)

VII Homogenization

244

(2)

VIII Metered-Dose Inhalers

246

(1)

IX Conclusions

247

(4)

References

248

(3)

7 Method Development for Pharmaceutical Chiral Chromatography

Gregory K. Webster

Laila Kott

I Introduction

251

(1)

II Overview of Chiral Separations

252

(1)

III Commercially Available Chiral Columns for Liquid Chromatography/Supercritical Fluid Chromatography

253

(1)

IV Commercially Available Chiral Columns for GC

254

(1)

V Preparative Chiral Chromatography

254

(13)

VI Chiral Method Development Screening

267

(5)

VII Chiral Detectors for LC/SFC Systems

272

(8)

VIII Summary and Conclusions

280

(3)

References

280

(3)

8 Characterization and Analysis of Biopharmaceutical Proteins

Yin Luo

Tatjana Matejic

Chee-Keng Ng

Brian Nunnally

Thomas Porter

Stephen Raso

Jason Rouse

Tanya Shang

John Steckert

I Introduction

283

(2)

II Structure

285

(22)

III Concentration

307

(8)

IV Purity

315

(5)

V Function

320

(29)

VI Summary and Conclusions

349

(12)

References

350

(11)

9 Preformulation and Early Phase Method Development

Kevin Coleman Bynum

I Introduction

361

(2)

II Preformulation API Physicochemical Properties

363

(10)

III Drug Product

373

(17)

IV Clinical Dosage Forms

390

(4)

V Conclusions

394

(4)

References

394

(4)

10 In-Process Control Testing

Christopher Wood

I Introduction

398

(1)

II API Process Control Overview

398

(6)

III Analysis Considerations

404

(1)

IV HPLC Method Development

405

(3)

V In-process Control Tests

408

(10)

VI Chromatographic IPC Validation

418

(3)

VII In-Process Control Test Technology Transfer

421

(2)

VIII Future Trends for In-Process Analysis

423

(1)

IX Summary

423

(7)

References

423

(7)

11 Validation of Analytical Test Methods

Alison E. Bretnall

Graham S. Clarke

I Background and
Chapter Overview

430

(2)

II Validation Terminology and Definitions

432

(1)

III Method Development and its Influence on Method Validation

433

(7)

IV Validation Requirements of the Method

440

(2)

V Validation Documentation

442

(1)

VI Validation Experimentation

443

(6)

VII Method Transfer

449

(2)

VIII Revalidation

451

(1)

IX Reference Standards

451

(3)

X Future Perspectives

454

(1)

XI Summary and Conclusions

455

(5)

References

455

(5)

12 Stability Studies

Jessica Cha

Timothy Gilmor

Philip Lane

Joseph S. Ranweiler

I Introduction

460

(1)

II Operational Aspects of Stability

461

(17)

III Excipients

478

(3)

IV Active Pharmaceutical Ingredient

481

(8)

V Drug Product

489

(13)

VI Summary and Conclusions

502

(5)

References

502

(5)

13 Analytical Methodology Transfer

Stephen Scypinski

Joel Young

I Introduction

507

(1)

II The Drug Development Process

508

(2)

III Types of Method Transfer

510

(2)

IV Pretransfer Activities

512

(3)

V Requirements and Elements of Analytical Technology Transfer

515

(4)

VI Protocol Execution

519

(1)

VII Analysis of Results/Statistical Packages

520

(1)

VIII Documentation of Results

521

(1)

IX Analyst Certification and Training

521

(1)

X Transfer of Technical Ownership

522

(3)

XI Summary

525

(2)

References

525

(2)

14 Pharmaceutical Analysis Documentation

Hitesh Chokshi

Kathleen Schostack

Richard Steinbach

I Scope

527

(1)

II Introduction

528

(1)

III Pharmaceutical Analysis During Product Life Cycle

529

(11)

IV Regulatory Documents

540

(7)

V Compliance Documents

547

(4)

VI Research Documents

551

(1)

VII Summary

552

(1)

VIII Conclusions

553

(10)

Index

563

Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017). Stephen Scypinski obtained his Ph.D. in analytical chemistry from Seton Hall University. He is director of analytical chemistry research and development department at R.W. Johnson Pharmaceutical Research Institute.

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