Cantitate/Preț
Produs
Total produse
Vezi coșul
Pharmaceutical Industry Practices on Genotoxic Impurities de Heewon Lee

Pharmaceutical Industry Practices on Genotoxic Impurities: Chromatographic Science Series

Editat de Heewon Lee
en Limba Engleză Hardback – 29 aug 2014
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
  • 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.
Citește tot Restrânge

Din seria Chromatographic Science Series

Preț: 99367 lei

Preț vechi: 133620 lei
-26% Nou

Puncte Express: 1491
Preț estimativ în valută:
19018€ • 20063$ • 15848£

Carte tipărită la comandă

Livrare economică 02-16 ianuarie 25

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781439874202
ISBN-10: 1439874204
Pagini: 536
Ilustrații: 493 black & white illustrations, 88 black & white tables
Dimensiuni: 156 x 234 x 33 mm
Greutate: 1.15 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Chromatographic Science Series

Public țintă

Professional Practice & Development

Cuprins

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.

Notă biografică

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.

Descriere

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.