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BIOAVAILABILITY REGULATIONS  (21CFR 320.1 320,62)

 

Subpart A             Definitions

Bioavailablility drug product, pharmaceutical equivalents, pharmaceutical alternatives, bioequivalent drug products, bioequivalence requirement

 

Subpart B             Requirements

Any original NDA/ANDA

Either bio data or waiver request

Supplements

If new indication or new dosage regimen and clinical study

required, need BIO data or waiver request

If change in manufacturing process, including formulation change or new strength, need bio data waiver request

FDA may request new biodata for approved NDA/ANDA if:

 Dosage regimen is based on incorrect pharmacokinetics 

Intra or inter batch variability

 

Waivers

General approaches

Guidelines

Conduct of studies

Design single dose

Design multiple dose

Several other sections

 

Subpart C        Bioequivalence Requirements

 

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