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. * Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies * Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH ...
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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. * Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies * Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines * Uses case studies to help readers understand and apply ICH guidelines * Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines * Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
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New. Sewn binding. Cloth over boards. 736 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
PLEASE NOTE, WE DO NOT SHIP TO DENMARK. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Please note we cannot offer an expedited shipping service from the UK.