quality guidelines implementation guide (3 Ergebnisse)

Hardcover. Zustand: Brand New. 1st edition. 721 pages. 9.00x6.25x1.25 inches. In Stock.

Buch. Zustand: Neu. Neuware - 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).

Zustand: New. 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, together with impact on marketed products. Num Pages: 464 pages. BIC Classification: PN; TDCW. Category: (P) Professional & Vocational. Weight in Grams: 666. . 2017. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.