Drugs

Geriatric Use Supplement PK/PD Category

FDA Data Element Number.

CDER Data Element Number. C-DRG-00915

Version Number. 001

Data Element Name. Geriatric Use Supplement PK/PD Category

Description. Geriatric Use Supplement PK/PD Category describes the pharmacokinetic and pharmacodynamic categories that are applicable to CDER Geriatric Use Supplements.

Source. 21CFR201.57 (f)(10).

Relationship.

FDA Specifications.

CDER Specifications. Geriatric Use Supplement PK/PD Category shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. (Reference table column_id = ger_use_sup_pkpd)

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
RAW DATA AND STUDY ANALYSIS Literal PR
LITERATURE Literal PL

 

Page Last Updated: 12/10/2014
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