Electronic Resource

Specification of drug substances and products : development and validation of analytical methods

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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.

Key Features :
* Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)
* Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities
* Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

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Ketersediaan

Informasi Detail

Judul Seri

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No. Panggil

E1388

Penerbit

Amsterdam : Elsevier., 2013

Deskripsi Fisik

viii, 380 hlm. : il.

Bahasa

English

ISBN/ISSN

9780080983509

Klasifikasi

NONE

Tipe Isi

text

Tipe Media

computer

Tipe Pembawa

online resource

Edisi

-

Subjek

Obat
Kimia Farmaseutika

Info Detail Spesifik

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Pernyataan Tanggungjawab

Edited by: Christopher M. Riley, Thomas W. Rosanske and Shelley R. Rabel Riley

Versi lain/terkait

Lampiran Berkas

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