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.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
"...a valuable addition to a pharmaceutical scientists’ library....relevant and of interest to various “stake-holders in the drug development arena, including chemists, analysts, and programme managers. I can recommend it."--Organic Process Research & Development Journal, Sep-14
"Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book is organized to offer a critical and comprehensive account of the approaches used to identify the key determinants of quality production that affect the safety, effectiveness, and marketability of a drug."--ProtoView.com, April 2014
Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.
Spese di spedizione:
GRATIS
In U.S.A.
Descrizione libro Condizione: New. New! This book is in the same immaculate condition as when it was published. Codice articolo 353-0080983502-new
Descrizione libro HRD. Condizione: New. New Book. Shipped from UK. Established seller since 2000. Codice articolo GB-9780080983509
Descrizione libro Condizione: New. Codice articolo 19607724-n
Descrizione libro Condizione: New. In. Codice articolo ria9780080983509_new
Descrizione libro Hardcover. Condizione: new. Codice articolo 9780080983509
Descrizione libro HRD. Condizione: New. New Book. Shipped from UK. Established seller since 2000. Codice articolo GB-9780080983509
Descrizione libro Hardback. Condizione: New. New copy - Usually dispatched within 4 working days. Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry practices of analytical methodologies used in the specification of drug substances and products. Codice articolo B9780080983509
Descrizione libro Buch. Condizione: Neu. Neuware - Subtitled, 'Development & Validation Of Analytical Methods'. Codice articolo 9780080983509
Descrizione libro Condizione: New. Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry prac. Codice articolo 5889021