1.

Record Nr.

UNINA9910876870703321

Titolo

Fundamentals of early clinical drug development : from synthesis design to formulation / / edited by Ahmed F. Abdel-Magid and Stephane Caron

Pubbl/distr/stampa

Hoboken, N.J., : Wiley-Interscience, c2006

ISBN

1-280-54982-3

9786610549825

0-470-04340-7

0-470-04339-3

Descrizione fisica

1 online resource (341 p.)

Altri autori (Persone)

Abdel-MagidAhmed F. <1947->

CaronStephane

Disciplina

615/.1

Soggetti

Clinical pharmacology

Pharmaceutical technology

Drugs - Testing

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Reflections on process research II / Edward J.J. Grabowski -- Development and scale-up of a heterocyclic cross-coupling for the synthesis of 5-(2-(3-methyl-3H-imidazol-4-yl)thieno(3,2-b)pyridin-7-yl)amino-2-methyl-1H-indol / John A. Ragan -- Large-scale enantioselective preparation of 2E,7E, 5S,6R, 5-hydroxy-6-methyl-8-phenyl-octa-2,7-dienoic acid, a key fragment for the formal total synthesis of the anti-tumor agent cryptophycin 52 / James Aikins ... [et al.] -- Efforts toward a commercially viable route and process to the synthesis of HIV PI GW640385X / John C. Roberts ... [et al.] -- Development of an asymmetric synthesis of ABT-100 / Albert W. Kruger ... [et al.] -- Asymmetric hydrogenation: a new route to pregabalin / Rex Jennings ... [et al.] -- Responsibilities of the process chemist: beyond synthetic organic chemistry / Stephane Caron -- Outsourcing: the challenge of science, speed, and quality / Simone Andler-Burzlaff, Jason Bertola, and Roger E. Marti -- Automation and the changing face of process research in the pharmaceutical industry /



Edward J. Delaney ... [et al.] -- Large scale synthesis: an engineering perspective / Joseph H. Childers, Jr. -- Synthesis and application of radioisotopes in pharmaceutical research and development / Larry E. Weaner and David C. Hoerr -- Selection of the drug form in exploratory development / George J. Quallich -- Strategies to control particle size of active pharmaceutical ingredients / David J. am Ende and Peter R. Rose -- Challenges in early formulation: turning drug substance into drug product / Mark H. Kleinman and Beeah Lee -- Intellectual property and early development / Maria I. Shchuka.

Sommario/riassunto

An informative look at the intricacies of today's drug development processOnce a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield.This book covers both re