Bioequivalence Analysis

At AmPharm Statistics, our team specializes in bioequivalence analysis for clinical trials. You can rest assured that we have extensive experience and understanding when it comes to showing equivalence between small molecules, biologics, long acting injectable formulations, topical products, transdermal patches, inhalation products, and more.  Our experience includes highly variable drugs, non-absorbed products, specialty generic products, biosimilar products, proteins, and more.

What are the Requirements for Demonstrating Bioequivalence?

Bioequivalence describes the in vivo and in vitro assessment of equivalence between a test product (T), which is developed exclusively to closely mimic the brand name product, and the Reference Listed Drug (i.e. RLD or R).  If all in vitro and in vivo studies demonstrate the products to be bioequivalent, they may be used interchangeably for the indications listed in the generic product labeling.

FDA has outlined, for many RLD products, the studies that are required to meet their bioequivalence standards.  These outlines are publicly available as “white paper guidance documents”, on the FDA website.

Per 21CFR 320.23, in brief, the in vivo bioavailability of a drug product is assessed by measuring the rate and extent of absorption of the active ingredient into the blood stream.  To demonstrate bioequivalence, this assessment is performed on both the T and R products in a cross-over study (or other similar designs).  Most commonly the parameters of plasma Cmax and AUC, and their respective T/R ratios are used to prove, or disprove equivalence.  The statistical techniques used must be of sufficient sensitivity to detect differences in rate and extent of absorption that are not attributable to subject variability.  Importantly, two drug products will be considered bioequivalent if they are pharmaceutical equivalents or pharmaceutical alternatives whose rate and extent of absorption do not show a significant difference when administered at the same molar dose of the active moiety under similar experimental conditions.  For drug products that are not intended to be absorbed into the bloodstream, bioequivalence may be demonstrated by scientifically valid methods that are expected to detect a significant difference between T and R in safety and therapeutic effect(s).

What AmPharm Statistics Offers for Bioequivalence Analysis

At AmPharm Statistics, our team can:

  • Plan and implement programs to develop bioequivalent formulations
  • In vitro screening studies
  • Implement and manage bioequivalent product development
  • Generate pilot and pivotal protocol designs
  • Data analysis and reporting on behalf of the Sponsor
  • Population bioequivalence
  • … and more!

Dosage forms include

  • Inhalation solution
  • Metered dose inhalers
  • Oral sprays
  • Nasal sprays
  • Topical sprays
  • Dry powder inhalers
  • Suspensions
  • Immediate release tablets
  • Controlled release tablets
  • Orally administered products that are not absorbed
  • … and more!

Why Choose AmPharm Statistics for Bioequivalence Analysis?

AmPharm Statistics was founded in 1994 and we have over two decades of experience in the bioequivalence arena.

If you want to know more about our bioequivalence analysis services, feel free to schedule an initial consultation today. You can email us at rmacarthur@researchpharmacy.com or call us at 844-674-3377.