Lot approval is an integral part of the approval of biological products. The approval procedure must prove that the potency of the lot is not significantly different than hypothetic of 100% potency. The paper investigates the current methodology (statistical) used by sponsors of biological products. It proposes additional statistical methodologies for lot approvals.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Intramural Research (Z01)
Project #
1Z01BS001002-01
Application #
5200884
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Division of Biologics Standards
Department
Type
DUNS #
City
State
Country
United States
Zip Code