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On assessing bioequivalence and interchangeability between generics based on indirect comparisons.

Publication ,  Journal Article
Zheng, J; Chow, S-C; Yuan, M
Published in: Stat Med
August 30, 2017

As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright © 2017 John Wiley & Sons, Ltd.

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Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

August 30, 2017

Volume

36

Issue

19

Start / End Page

2978 / 2993

Location

England

Related Subject Headings

  • Zidovudine
  • Therapeutic Equivalency
  • Statistics & Probability
  • Models, Statistical
  • Malaria
  • Lumefantrine
  • Lamivudine
  • Humans
  • HIV Infections
  • Fluorenes
 

Citation

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Zheng, J., Chow, S.-C., & Yuan, M. (2017). On assessing bioequivalence and interchangeability between generics based on indirect comparisons. Stat Med, 36(19), 2978–2993. https://doi.org/10.1002/sim.7326
Zheng, Jiayin, Shein-Chung Chow, and Mengdie Yuan. “On assessing bioequivalence and interchangeability between generics based on indirect comparisons.Stat Med 36, no. 19 (August 30, 2017): 2978–93. https://doi.org/10.1002/sim.7326.
Zheng J, Chow S-C, Yuan M. On assessing bioequivalence and interchangeability between generics based on indirect comparisons. Stat Med. 2017 Aug 30;36(19):2978–93.
Zheng, Jiayin, et al. “On assessing bioequivalence and interchangeability between generics based on indirect comparisons.Stat Med, vol. 36, no. 19, Aug. 2017, pp. 2978–93. Pubmed, doi:10.1002/sim.7326.
Zheng J, Chow S-C, Yuan M. On assessing bioequivalence and interchangeability between generics based on indirect comparisons. Stat Med. 2017 Aug 30;36(19):2978–2993.
Journal cover image

Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

August 30, 2017

Volume

36

Issue

19

Start / End Page

2978 / 2993

Location

England

Related Subject Headings

  • Zidovudine
  • Therapeutic Equivalency
  • Statistics & Probability
  • Models, Statistical
  • Malaria
  • Lumefantrine
  • Lamivudine
  • Humans
  • HIV Infections
  • Fluorenes