{"product_id":"ich-quality-guidelines-an-implementation-guide-9781118971116","title":"Ich Quality Guidelines: An Implementation Guide","description":"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.\u003cbr\u003e\u003cbr\u003e- Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies\u003cbr\u003e- Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines\u003cbr\u003e- Uses case studies to help readers understand and apply ICH guidelines\u003cbr\u003e- Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines\u003cbr\u003e- Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Andrew Teasdale\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Wiley\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/09\/2017\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 736\u003cbr\u003e\u003cb\u003eBinding Type:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.45lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.10h x 6.30w x 1.60d\u003cbr\u003e\u003cb\u003eISBN:\u003c\/b\u003e 9781118971116\u003cbr\u003e\u003cp\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003e Andrew Teasdale, PhD, \u003c\/b\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e David Elder, PhD, \u003c\/b\u003e is an independent CMC consultant. He has 40 years' experience within the pharmaceutical industry. He was formerly a director within GlaxoSmithKline's platform technology and science function. He is an expert member for the British Pharmacopoeia and has extensive CMC experience encompassing many of the key ICH topics.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e Raymond W. Nims, PhD, \u003c\/b\u003e 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.\u003c\/p\u003e\u003cbr\u003e","brand":"Wiley","offers":[{"title":"Hardcover","offer_id":40833163722867,"sku":"9.78112E+12","price":498.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0555\/9255\/0515\/products\/img_58865793-8f29-44e8-8dbc-ed3cb68c2f2f.jpg?v=1684848158","url":"https:\/\/bookstorenmore.com\/en-de\/products\/ich-quality-guidelines-an-implementation-guide-9781118971116","provider":"Bookstore N More","version":"1.0","type":"link"}