TY - BOOK ID - 88199213 TI - Accelerated predictive stability : fundamentals and pharmaceutical industry practices AU - Qiu, Fenghe AU - Scrivens, Garry PY - 2018 SN - 9780128027851 0128027851 012802786X 9780128027868 PB - San Diego, California : Elsevier, DB - UniCat KW - Drug stability. KW - Pharmaceutical industry. KW - Drug industry KW - Drug trade KW - Medicine industry KW - Medicines industry KW - Prescription medicine industry KW - Chemical industry KW - Drugs KW - Stability, Drug KW - Pharmacology KW - Stability UR - https://www.unicat.be/uniCat?func=search&query=sysid:88199213 AB - "Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS). Presents the scientific basis of different APS models. Includes the applications and utilities of APS that are demonstrated through numerous case studies. Covers up-to-date regulatory experience"-- ER -