Több mint 10 millió cím angol és más nyelveken! Fedezd fel új történetedet még ma!

Mutagenic Impurities - Strategies for Identification and Control

Name: Mutagenic Impurities - Strategies for Identification and Control
Brand: John Wiley and Sons Ltd
SKU: 9781119551218
Price: 81335 HUF
Availability: InStock

Szerző: Andrew Teasdale

Nyelv:

Kötés: Kemény kötésű

Kiadó: John Wiley and Sons Ltd

Elérhetőség: Beszállítói készleten

Küldés 14-21 napon belül

81 335 Ft

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development...

Információk a könyvről

Szerző

Andrew Teasdale

Nyelv

Angol

Kötés

Könyv - Kemény kötésű

Kiadva

2022

oldal

544

EAN

9781119551218

ISBN

1119551218

Enbook ID

24989005

Kiadó

John Wiley and Sons Ltd

Súly

1204

Méretek

262 x 183 x 40

Teljes leírás

Learn to implement effective control measures for mutagenic impurities in pharmaceutical developmentIn Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective.The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment.The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination.Readers will also benefit from the inclusion of:* A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline* An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities* A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagentsPerfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.