Vinod P. Shah, Ph. D., FIP/Chair SIG on Regulatory Sciences
Pharmaceutical Consultant, North Potomac, MD

The mission of a regulatory authority is to assure that safe and effective drugs are marketed in the country and are available to the people. FDA ensures that the generic drug products are safe and effective, are pharmaceutically equivalent and bioequivalent to the brand-name counterparts. Generic drugs have to meet the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

• Contain the same active ingredient as the innovator drug (inactive ingredients may vary)
• In identical strength, dosage form, and route of administration
• Have the same use indications (labeling)
• Be bioequivalent
• Meet the same batch requirements for identity, strength, purity and quality
• Be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products.

Most common method to establish bioequivalence is thru measurement of drug and/or metabolites in biological fluid, plasma or serum. Various methods of establishing bioequivalence will be discussed briefly.
The drug product safety and efficacy for the generic product is established by it being pharmaceutically equivalent and bioequivalent, and thus therapeutically equivalent. The quality of the product is ensured thru product identity, strength, purity, assay, potency, content uniformity, dissolution (for solid oral dosage forms) and being manufactured under FDA’s good manufacturing practice. The approved drug product should also conform to the drug product performance criteria.
There are certain classes of drug products, where it is difficult to assess BE by general methods. These classes of drug products include:

• Highly variable drug and drug products,
• Orally administered non-absorbed drug products,
• Topically administered dosage forms,
• Nasal and Inhalation aerosols.

Presented at 2nd Zagreb International Conference on Pharmaceutical Sciences, Zagreb, Croatia, October 25-26, 2013