1.

Record Nr.

UNINA9910698976903321

Titolo

Revision of the ICH guideline on clinical safety data management [[electronic resource] ] : data elements for transmission of individual case safety reports

Pubbl/distr/stampa

[Rockville, MD] : , : [Center for Drug Evaluation and Research] : , : [Center for Biologics Evaluation and Research], , [2005]

Descrizione fisica

25 pages : digital, PDF file

Soggetti

Clinical pharmacology

Clinical trials - Reporting

Drugs - Testing

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Title from PDF title page (viewed on June 18, 2009).

"ICH harmonised tripartite guideline".

"Version 2.0".

"12 May 2005".