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Development and Validation of Analytical Methods, 2e

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437.41  Lei 514.6  Lei

sau 43741 de puncte. Detalii.

Indisponibil

Cod: BRT9780080983509

An aparitie: 2013

Autor: C M Riley

Categoria: Industrial chemistry & manufacturing

Data aparitie: 17092013

Editie: cartonata

Editura: Elsevier Science & Technology

Format: 249 x 198 x 28 mm

Limba: English

Nr. pagini: 390

Tip: Hardback

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.

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