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魅麗。花火原創小說66折起
Ich Quality Guidelines: An Implementation Guide
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Ich Quality Guidelines: An Implementation Guide

定  價:NT$ 16873 元
優惠價:9015186
若需訂購本書,請電洽客服 02-25006600[分機130、131]。
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商品簡介

This book focuses on the quality guidelines and requirements of multi-disciplinary International Conference on Harmonization (ICH) topics, and examines the implications and practical implementation. The challenge of interpreting and implementing the guidelines faces the entire pharmaceutical industry, and the book offers a succinct and definitive text with practical case study examples. Topics include stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). The book provides a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of the guidelines, giving not only a definitive narrative, but also actual solutions to effectively manage the associated identified issues.

作者簡介

Andrew Teasdale, PhD,?is a principal scientist in pharmaceutical development with AstraZeneca. He has over 20 years’ experience within the industry and has held a number of leadership roles both internally and externally at a cross industry level encompassing key ICH topic areas.

David Elder, PhD,?is a director within GlaxoSmithKline’s (GSK) platform technology and science (PTS) function. He has 23 years’ experience at GSK and another 16 within the pharmaceutical industry, at Sterling Winthrop and Syntex.
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Raymond Nims, PhD, is a Senior Consultant at RMC Pharmaceutical Solutions, with experience in a variety of GMP quality assurance and quality control topics from a biologics point of reference. ?He has served on ad hoc panels supporting a number of USP chapters and ANSI Standards.

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優惠價:90 15186
若需訂購本書,請電洽客服 02-25006600[分機130、131]。

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