Research Catalog

Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.

Title
Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
Publication
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2003]

Available Online

https://purl.fdlp.gov/GPO/LPS113056

Details

Additional Authors
  • Center for Biologics Evaluation and Research (U.S.)
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Veterinary Medicine (U.S.)
Description
iii, 19 : digital, PDF file
Alternative Title
Comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
Subject
  • Medical protocols > Government policy > United States
  • Protein drugs > United States
  • Biological products > Therapeutic use > United States
Note
  • Title from PDF title page (viewed on May 26, 2009).
  • "Draft guidance".
  • "September 2003".
System Details (note)
  • Mode of access: Internet at the GPO Access web site. Address as of 5/26/09: http://www.fda.gov/cber/gdlns/protcmc.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4802:P 94/2
OCLC
marcive351551610
Title
Guidance for industry : comparability protocols, protein drug products and biological products; chemistry, manufacturing, and controls information.
Publisher
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Veterinary Medicine, [2003]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
System Details
Mode of access: Internet at the GPO Access web site. Address as of 5/26/09: http://www.fda.gov/cber/gdlns/protcmc.pdf ; current access is available via PURL.
Connect to:
https://purl.fdlp.gov/GPO/LPS113056
Added Author
Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
Center for Veterinary Medicine (U.S.)
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:P 94/2
View in Legacy Catalog