Pharmaceutical Industry Practices on Genotoxic Impurities
Crc Press Inc (Verlag)
978-1-4398-7420-2 (ISBN)
Explores the safety, quality, and regulatory aspects of GTIs
Provides an overview of the latest FDA and EMEA guidelines
Explains the how and why of various GTI control tactics and practices
Describes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing
Includes real-life examples of GTI control in drug substance and drug product development processes
Containing case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of—and a current framework for—GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.
Heewon Lee is Senior Associate Director of the Chemical Development Department at Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA. She is also leader of the Analytical Research Group, an active participant in the Genotoxic Impurity Council, and a member of the Pharmaceutical IQ Consortium Working Group. She holds a BS and a MS from Seoul National University, South Korea, as well as a Ph.D from the University of Michigan, Ann Arbor, USA. Previously, she worked at ArQule, a biotechnology company located in Woburn, Massachusetts, USA. After ArQule, she joined the Medicinal Chemistry Department at Boehringer-Ingelheim before moving to her current position.
Overview of Regulatory Guidelines on Impurities and Genotoxic Impurities. Structural Alerts for Genotoxicity and Carcinogenicity. Acceptable Exposure Calculations for Impurities and Selected Compounds from the Carcinogenic Potency Database. Genotoxic Impurities from Toxicology Perspectives Including Cancer Risk Assessment, In Silico, In Vitro/In Vivo Testings, and Regulatory Aspects. In Silico/Computational Assessment for the Evaluation of Genotoxic Impurities. Preclinical Assessment of Genotoxic Impurities: An Overview of Current Regulatory Guidance, Available Assays, and Data Interpretation. Purification of Lead Compounds for Early Toxicology Profiling such as Ames and Short-Term Nongood Laboratory Practice Toxicology Tests. Analysis of Genotoxic Impurities in Pharmaceuticals by Gas Chromatography–Mass Spectrometry. Control of Chloroethane in Raw Materials and Drug Substances Using Headspace/Gas Chromatography Analysis. Quantification of Genotoxic Impurities in Active Pharmaceutical Ingredients. Analytical Testing and Control for Genotoxic Impurities in Drug Substances. Approaches to Assess, Analyze, and Control Genotoxic Impurities in Drug Substance Development. Control and Analysis of Genotoxic Impurities in Drug Substance Development. Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks. Identification and Control of Genotoxic Degradation Products. Identification and Qualification of Genotoxic Impurities as Leachables in Drug Products. Pharmaceutical Industry Survey on Genotoxic Impurities and Related Topics.
| Erscheint lt. Verlag | 4.9.2014 |
|---|---|
| Reihe/Serie | Chromatographic Science Series |
| Zusatzinfo | 88 Tables, black and white; 493 Illustrations, black and white |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 1150 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Studium ► 2. Studienabschnitt (Klinik) ► Humangenetik | |
| Naturwissenschaften ► Biologie | |
| Naturwissenschaften ► Chemie ► Analytische Chemie | |
| Technik | |
| ISBN-10 | 1-4398-7420-4 / 1439874204 |
| ISBN-13 | 978-1-4398-7420-2 / 9781439874202 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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