Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter
By: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Contributors: International Conference on Harmonisation
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
Published: 2007
Place of publication: Rockville, MD
Language: eng
Format: [electronic resource] /
Subjects: Parenteral therapy
Other titles: Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter
Notes: Title from PDF title page (viewed on Apr. 30, 2009).

"Draft consensus guideline".

"Current step 2 version, dated October 30, 2007".

Includes bibliographical references (p. [4]).

Mode of access: Internet at the FDA CBER web site. Address as of 4/30/09: http://www.fda.gov/cber/gdlns/ichq4bann2.pdf; current access is available via PURL.