Pharmaceutical Industry Practices on Genotoxic Impurities By: Heewon Lee Publisher: routledge Print ISBN: 9781439874202, 1439874204 eText ISBN: 9781439874219, 1439874212 Edition: 1st Copyright year: 2014 Format: PDF Available from $ 23.18 USD SKU 9781439874219R90 A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: Explores the safety, quality, and regulatory aspects of GTIs Provides an overview of the latest FDA and EMEA guidelines Explai Download ebook: https://ouo.io/5nb9AI