1.

Record Nr.

UNINA9910811438303321

Titolo

Pharmaceutical toxicology in practice : a guide for non-clinical development / / edited by Alberto Lodola, Jeanne Stadler

Pubbl/distr/stampa

Hoboken, N.J., : John Wiley & Sons, c2011

ISBN

9786613072238

9780470922729

0470922729

9781283072236

1283072238

9780470909911

0470909919

9780470909904

0470909900

Edizione

[1st ed.]

Descrizione fisica

1 online resource (268 p.)

Altri autori (Persone)

LodolaAlberto

StadlerJeanne

Disciplina

615/.7040724

Soggetti

Drugs - Toxicity 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

The regulatory environment / Claudio Bernardi and Marco Brughera --Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty -- Contract research organizations / Maurice Cary -- Safety pharmacology / Claudio Arrigoni and Valeria Perego -- Formulations, impurities and toxicokinetics / Claude Charuel -- General toxicology / Alberto Lodola -- Genetic toxicology / Peggy Guzzie-Peck, Jennifer Sasaki, and Sandy Weiner -- Developmental and reproductive toxicology / Jeanne Stadler -- Data analysis, report writing and regulatory documentation / Monique Y. Wells -- Risk management / Alberto Lodola.

Sommario/riassunto

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an



understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in t