Freshly Printed - allow 7 days lead
Couldn't load pickup availability
ICH Quality Guidelines
An Implementation Guide
Andrew Teasdale (Edited by), A Teasdale (Author), David Elder (Edited by), Raymond W. Nims (Edited by)
9781118971116, Wiley
Hardback, published 15 December 2017
736 pages
23.4 x 15.8 x 3.8 cm, 1.225 kg
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.
• Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
• Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
• Uses case studies to help readers understand and apply ICH guidelines
• Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
• Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
List of Contributors ix An Introduction to ICH Quality Guidelines: Opportunities and Challenges 1 1 ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms 3 2 Stability Testing: Photostability Testing of New Drug Substances and Products ICH Q1B 45 3 ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 73 4 ICH Q1E Evaluation for Stability Data 89 5 Q2(R1) Validation of Analytical Procedures: Text and Methodology 127 6 Impurities in New Drug Substances and New Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity Management Process 167 7 ICH Q3C Impurities: Guideline for Residual Solvents 199 8 ICH Q3D Elemental Impurities 233 9 ICH Q4: Pharmacopeial Harmonization and Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions 281 10 ICH Q5A: Viral Safety of Biotechnology Products 311 11 ICH Q5B Analysis of the Expression Construct in Cell Lines Used for Production of Recombinant DNA‐Derived Protein Products 337 12 ICH Q5C Stability Testing of Biotechnological/Biological Products 345 13 Q5D Derivation and Characterization of Cell Substrates Used for Production ofBiotechnological/Biological Products 375 14 Conduct of Risk Assessments: An Integral Part of Compliance with ICH Q5A and ICH Q5D 395 15 ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Processes: Summary and Analysis of ICH Q5E Guideline 409 16 ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances 433 17 ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 467 18 Process‐Related Impurities in Biopharmaceuticals: A Deeper Dive into Ich Q6b 487 19 ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) 509 20 Q8(R2): Pharmaceutical Development 535 21 ICH Q9 Quality Risk Management 579 22 ICH Q10 Quality Systems: ICH Q10 Implementation at Genentech/Roche 611 23 ICH Q11: Development and Manufacture of Drug Substance 639 24 ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk 667 Index 701
Andy Rignall
David Clapham
Raymond Peter Munden
Garry Scrivens
Phillip Borman and David Elder
Andrew Teasdale, David Elder, James Harvey, and Steven Spanhaak
John Connelly
Andrew Teasdale and Sarah Thompson
David Elder
Daniel Galbraith
Jianxin Ye, Zhong Liu, and David Pollard
John G. Davies, Di Gao, Yoen Joo Kim, Richard Harris, Patricia W. Cash, Timothy L. Schofield, Roujian Zhang, and Qiang Qin
Mark Plavsic
Raymond W. Nims
Ramani R. Raghavan and Robert McCombie
David Elder
Scott R. Rudge and Raymond W. Nims
Anil Raghani, Kim Li, Jeanine L. Bussiere, Joel P. Bercu, and Jinshu Qiu
Gordon Munro
Per Holm, Morten Allesø, Mette C. Bryder, and René Holm
David Elder and Andrew Teasdale
Larry Wigman and Danny Ooi
Ronald Ogilvie
Andrew Teasdale
Subject Areas: Chemistry [PN]
