Drug Product Performance

Loshieni Shri Gunasegaran

260110152020
Drug Product Performance
Bioavailability studies is used to
Is defined as the release of the
It is important since define the effect of changes in
drug substance from the drug
bioavailability is related both to the physicochemical properties,
product leading to
the pharmacodynamic the formulation, and the
bioavailability of the drug
response and to adverse events manufacture process of the
substance.
drug product

Bioavailability and
Drug product performance
bioequivalence can be
studies are used in the
considered as measures of the
development of new and
drug product performance in
generic drug products
vivo
Bioequivalence Studies in New Drug
Development (NDA)
• Bioequivalence studies are used to compare
1. Early and late clinical trial formulations
2. Formulations used in clinical trials and stability studies, if different;
3. Clinical trial formulations and to-be-marketed drug products, if
different;
4. Product strength equivalence, as appropriate.
• Bioequivalence study designs are used to support new formulations
of previously approved products, such as a new fixed-dose
combination version of two products approved for coadministration,
or modified-release versions of immediate-release products.

Drug product performance may be determined in vivo by bioequivalence studies or in vitro by

comparative drug dissolution studies.
Drug Product Performance and Generic Drug
Development
• The initial safety and clinical efficacy studies during new drug
development may use a simple formulation.
• If the new drug demonstrates appropriate human efficacy and safety,
a to-be-marketed drug product (eg, compressed tablet) may be
developed.
• The marketed drug product that is approved by the US Food and Drug
Administration (FDA) may not be the same formulation that was used
in the original safety and clinical efficacy studies.
Drug Product Performance and Generic Drug
Development

These changes to the The manufacturer must

After the drug product is marketed drug product are Drug product performance
demonstrate that drug product
approved by the FDA and known as postapproval may be determined by in vivo
performance did not change
marketed, the manufacturer changes, often termed SUPAC bioequivalence studies or by in
and is the same for the drug
may perform changes to the (scale-up and postapproval vitro comparative drug release
product manufactured before
formulation. change based on several FDA or dissolution profiles.
and after the SUPAC change
guidance documents),
Generic Drug Product
Bioequivalence Studies in Generic Drug
Development (ANDA)
• A generic drug product is a multisource drug product that has been
approved by the FDA as a therapeutic equivalent to the reference
listed drug product and has proven equivalent drug product
performance.
• Since the formulation and method of manufacture of a drug product
can affect the bioavailability and stability of the drug, the generic drug
manufacturer must
1. Demonstrate that the generic drug product is pharmaceutically
equivalent, bioequivalent, and therapeutically equivalent to the
comparator brand-name drug product.
2. For any postapproval change, the manufacturer must demonstrate
that the change did not alter the performance of the drug product.
• Drug product performance comparison for oral generic drug products
is usually measured by
1. In vivo bioequivalence studies in normal healthy adult subjects under
fasted and fed conditions
2. In vitro comparison may also include comparative drug
dissolution/release profiles.