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Some thoughts on drug interchangeability.

Shein-Chung Chow1, Fuyu Song2, Meng Chen1

  • 1a Department of Biostatistics and Bioinformatics, Duke University School of Medicine , Durham , North Carolina , USA.

Journal of Biopharmaceutical Statistics
|September 15, 2015
PubMed
Summary
This summary is machine-generated.

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Current generic drug approval relies on average bioequivalence, but interchangeability between different generic versions is not guaranteed. This study examines criteria for assessing drug interchangeability to ensure safety and therapeutic equivalence.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Regulatory Affairs
  • Pharmacokinetics

Background:

  • Generic drug approval currently focuses on average bioequivalence to the reference listed drug.
  • The United States Food and Drug Administration (FDA) permits substitution of generics but does not guarantee interchangeability between different generic products of the same innovator drug.
  • With an increasing number of generic options, concerns arise regarding the quality, therapeutic effect, and interchangeable use of these products.

Purpose of the Study:

  • To evaluate existing criteria for assessing drug interchangeability.
  • To introduce and analyze a novel criterion for determining drug interchangeability.
  • To discuss study designs and power calculations for sample size determination in the context of drug interchangeability studies.

Main Methods:

Keywords:
Biosimilarsgeneric drugsindividual bioequivalence (IBE)population bioequivalence (PBE)scaled average bioequivalence (SABE)scaled criterion for drug interchangeability (SCDI)

Related Experiment Videos

  • Review of current regulatory standards for generic drug approval and bioequivalence.
  • Exploration of various criteria for assessing drug interchangeability.
  • Consideration of statistical methodologies, including power calculations, for designing interchangeability studies.

Main Results:

  • Current average bioequivalence assessments may not be sufficient to ensure interchangeability between different generic drugs.
  • A new criterion for assessing drug interchangeability is proposed and analyzed.
  • The article provides insights into appropriate study designs for evaluating drug interchangeability.

Conclusions:

  • There is a need for enhanced criteria beyond average bioequivalence to ensure the interchangeability of generic drugs.
  • The proposed criterion offers a potential framework for evaluating the therapeutic equivalence and safety of interchangeable generic products.
  • Further research and specific study designs are crucial for establishing drug interchangeability in the pharmaceutical market.