Christopher M. Riley - Böcker
Specification of Drug Substances and Products
Development and Validation of Analytical Methods
2 143 kr
Skickas inom 7-10 vardagar
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
Presents a critical assessment of the application of ICH guidelines on method validation and specification settingWritten by subject-matter experts involved in the development and application of the guidelinesProvides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and productsCovers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Specification of Drug Substances and Products
Development and Validation of Analytical Methods
2 569 kr
Skickas inom 7-10 vardagar
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the second edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products.
Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions.Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug-device combinationproducts such as digital drug delivery systems, transdermal systems, and inhalation products.Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data).