Pharmaceutical Industry Practices on Genotoxic Impurities (eBook, PDF)

Redaktion: Lee, Heewon

• Format: PDF

Produktbeschreibung

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists. This book strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, practices, and case studies from the pharmaceutical industry. Exploring the safety, quality, and regulatory aspects of GTIs, the text explains the how and why of various GTI control tactics and practices, including GTI control examples in drug substance and drug product development processes from large and small pharmaceutical firms in multiple geographical regions.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 536
• Erscheinungstermin: 29. August 2014
• Englisch
• ISBN-13: 9781439874219
• Artikelnr.: 43975712

Autorenporträt

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.

Inhaltsangabe

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.