To bring a generic drug to the U.S. market, sponsors must file an Abbreviated New Drug Application (ANDA) with the FDA. A key requirement of the ANDA process is proving bioequivalence (BE) between the proposed generic and the reference listed drug (RLD). Bioequivalence demonstrates that the generic delivers the same therapeutic effect, safety, and efficacy as the innovator drug.

Bioequivalence (BE) and Bioavailability (BA) studies play a crucial role in establishing therapeutic equivalence. These studies measure the rate and extent of drug absorption, ensuring that the generic performs comparably to the branded product in human subjects.

Typical requirements for BE/BA studies include:

• Study Design – Randomized, crossover studies comparing the generic drug with the RLD.
• Pharmacokinetic (PK) Analysis – Measurement of parameters such as Cmax, Tmax, and AUC.
• Subject Selection – Healthy volunteers or patient populations depending on therapeutic area.
• Statistical Evaluation – Confidence intervals (usually 90%) for key PK parameters within FDA acceptance criteria.

Conducting these studies requires expertise in regulatory strategy, clinical research, and data integrity. Most sponsors collaborate with a Contract Research Organization (CRO) to perform the clinical and analytical phases of BE studies.

At XPRO America, we specialize in ANDA Bioequivalence Studies Coordination by:

• Guiding BE/BA Requirements – Assessing the FDA expectations for specific drug categories.
• Study Protocol Design – Drafting study designs compliant with FDA guidelines.
• CRO Selection & Oversight – Connecting sponsors with qualified CROs and ensuring study execution meets regulatory standards.
• Regulatory Submissions – Preparing and submitting BE study data within the ANDA package in eCTD format.
• Compliance Support – Ensuring Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards are met.

Our services help sponsors minimize delays, reduce risks, and achieve timely FDA approvals for their generic drug products. By aligning scientific requirements with regulatory expectations, XPRO America ensures your ANDA bioequivalence studies are executed with precision.

XPRO America provides ANDA bioequivalence (BE/BA) study support, protocol design, CRO coordination, and FDA-compliant submissions for generic drug approvals.