Research Catalog

Details

Additional authors

1. Center for Drug Evaluation and Research (U.S.)
2. International Conference on Harmonisation.

Description

1. iii, 20 pages : digital, PDF file

Alternative title

1. Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

Subject

1. Drugs > Testing
2. Clinical trials

Call number

1. GPO Internet HE 20.4802:N 73

Note

1. Title from PDF title page (viewed on Apr. 9, 2008).
2. "ICH harmonised tripartate guideline."
3. "M3(R2)."
4. "Current step 2 version dated 15 July, 2008."
5. Includes bibliographical references (p. 19-20).

System details (note)

1. Mode of access: Internet at the FDA CBER Web site. Address as of 4/09/09: http://www.fda.gov/cder/guidance/8500dft.pdf ; current access is available via PURL.

Title

1. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.

Publisher

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

Type of content

1. text

Type of medium

1. computer

Type of carrier

1. online resource

System details

1. Mode of access: Internet at the FDA CBER Web site. Address as of 4/09/09: http://www.fda.gov/cder/guidance/8500dft.pdf ; current access is available via PURL.

Connect to:

1. https://purl.fdlp.gov/GPO/LPS111169

Added author

1. Center for Drug Evaluation and Research (U.S.)
2. International Conference on Harmonisation.

Gpo item no.

1. 0499-T-02 (online)

Sudoc no.

1. HE 20.4802:N 73