S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.

Format:

Book

Conference/Event

Government document

Contributor:

Center for Drug Evaluation and Research (U.S.)

Conference Name:

International Conference on Harmonisation http://viaf.org/viaf/130234339

Language:

English

Subjects (All):

Genetic toxicology.

Drugs--Testing.

Drugs.

Physical Description:

1 online resource (37 pages)

Other Title:

P. 1 has title: Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use

Genotoxicity testing and data interpretation for pharmaceuticals intended for human use

Place of Publication:

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2008]

Notes:

Title from title screen (viewed on June 17, 2009).

"ICH harmonized tripartite guideline"--Page 1

"Draft January 28th 2008; version 5.3"--Page 1

Includes bibliographical references (pages 35-37).

OCLC:

401790357