Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.

Format:

Book

Conference/Event

Government document

Contributor:

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

Conference Name:

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

Language:

English

Subjects (All):

Drug monitoring.

Drugs--Microbiology--Testing.

Drugs.

Drugs--Side effects--Reporting.

Pharmacovigilance.

Physical Description:

1 online resource (10 pages)

Other Title:

ICH regions on Sterility Test General Chapter

Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions

Place of Publication:

[Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research]

Notes:

Title from PDF title page (viewed on March 20, 2009).

"Current step 2 version 1, dated 13 November 2008."

"Draft consensus guideline."

"Q4B annex 8."

Includes bibliographical references (page 2).

OCLC:

316535700