Research Catalog

Title

Guidance for industry : submission of summary bioequivalence data for ANDAs.

Publication

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]

Details

Additional Authors

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

Description

i, 9 pages : digital, PDF file

Alternative Title

Submission of summary bioequivalence data for ANDAs

Subject

• Drugs > United States > Therapeutic equivalency
• Drugs > Certification > United States

Note

• Title from title screen (viewed on May 5, 2009).
• "Draft guidance."
• "April 2009."

System Details (note)

• Mode of access: Internet from the CDER web site. Address as of 5/5/09: http://www.fda.gov/cder/guidance/8363dft.pdf; current access available via PURL.

Call Number

GPO Internet HE 20.4702:B 52/DRAFT

OCLC

marcive320234159

Title

Guidance for industry : submission of summary bioequivalence data for ANDAs.

Publisher

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

Mode of access: Internet from the CDER web site. Address as of 5/5/09: http://www.fda.gov/cder/guidance/8363dft.pdf; current access available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS112216

Added Author

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

Gpo Item No.

0499-T (online)

Sudoc No.

HE 20.4702:B 52/DRAFT