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SMG 1264.53

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF TESTING AND RESEARCH

DIVISION OF PRODUCT QUALITY RESEARCH

Effective Date: 09/14/1996

Transmittal Number 98-36 -- Date: 07/22/1998

[PDF Version]

1. DIVISION OF PRODUCT QUALITY RESEARCH (DBNSDC).

A. Plans and conducts research to study the impact on product quality, including changes in specifications of bulk drug substance, formulation (including packaging, design and materials), component and composition, and manufacturing equipment and processes.

B. Plans and conducts research to investigate the utility of diverse physical, chemical, and biological in vitro test systems for the accurate measurement or prediction of product quality attributes.

C. Plans and conducts research to evaluate safety, functionality and/or control of new excipients, vehicles and drug formulation, and delivery approaches.

D. Plans and conducts research to develop new or improved metric(s) and statistical procedures for bioequivalence determination and to develop and improve mathematical/computer systems for prediction of bioavailability/bioequivalence.

E. Provides expert advice to the drug review divisions and other scientific and regulatory units of the Center on the Chemistry, Manufacturing and Controls, the Biopharmaceutics, and other relevant sections, of new drug applications, abbreviated new drug applications, and abbreviated antibiotic drug applications.

F. Develops and validates pharmacological/biological methods to asses bioequivalence of drug products as required to reflect drug action and/or bioavailability.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Director, Center for Drug Evaluation and Research on September 14, 1996.