ICH quality guidelines : an implementation guide / edited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA.

"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)"-- Provided by publisher.

An Introduction to ICH Quality Guidelines -- ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms / Andy Rignall -- Stability Testing / David Clapham -- ICH Q1D / Raymond Peter Munden -- ICH Q1E Evaluation for Stability Data / Garry Scrivens -- Q2(R1) Validation of Analytical Procedures / Phillip Borman, David Elder -- Impurities in New Drug Substances and New Drug Products / Andrew Teasdale, David Elder, James Harvey, Steven Spanhaak -- ICH Q3C Impurities / John Connelly -- ICH Q3D Elemental Impurities / Andrew Teasdale, Sarah Thompson -- ICH Q4 / David Elder -- ICH Q5A / Daniel Galbraith -- ICH Q5B Analysis of the Expression Construct in Cell Lines Used for Production of Recombinant DNA-Derived Protein Products / Jianxin Ye, Zhong Liu, David Pollard -- ICH Q5C Stability Testing of Biotechnological/Biological Products / John G Davies, Di Gao, Yoen Joo Kim, Richard Harris, Patricia W Cash, Timothy L Schofield, Roujian Zhang, Qiang Qin -- Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products / Mark Plavsic -- Conduct of Risk Assessments / Raymond W Nims -- ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Processes / Ramani R Raghavan, Robert McCombie -- ICH Q6A Specifications / David Elder -- ICH Q6B Specifications / Scott R Rudge, Raymond W Nims -- Process-Related Impurities in Biopharmaceuticals / Anil Raghani, Kim Li, Jeanine L Bussiere, Joel P Bercu, Jinshu Qiu -- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (APIs) / Gordon Munro -- Q8(R2) / Per Holm, Morten Allesø, Mette C Bryder, René Holm -- ICH Q9 Quality Risk Management / David Elder, Andrew Teasdale -- ICH Q10 Quality Systems / Larry Wigman, Danny Ooi -- ICH Q11 / Ronald Ogilvie -- ICH M7 / Andrew Teasdale.

Includes bibliographical references and index.

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