Pharmacogenetic Perspectives in Improving Pharmacokinetic Profiles for Efficient Bioequivalence Trials with Highly Variable Drugs

Authors

  • Ali Taer Ali Alasmari Pharmacist, Armed Force Hospital Southern Region, Asir, Saudi Arabia
  • Ali Mohammed Ahmed Qaysi Pharmacist, Armed Force Hospital Southern Region, Asir, Saudi Arabia
  • Musaed Abdullah Alqahtani Pharmacist, Armed Force Hospital Southern Region, Asir, Saudi Arabia
  • Abdullah Mohammed Ibn Makdah Pharmacist, Armed Force Hospital Southern Region, Asir, Saudi Arabia
  • Abdulaziz Fayhan Almutairi Pharmacist, Armed Force Hospital Southern Region, Asir, Saudi Arabia

DOI:

https://doi.org/10.29070/zzfa6m26

Keywords:

Bioequivalence, pharmacogenetics, highly variable drugs, pharmacokinetics, genetic polymorphisms, drug metabolism, adaptive trial design, inter-subject variability, pharmacokinetic profiling

Abstract

Highly variable drugs (HVDs), characterized by an intra-subject coefficient of variation (CV%) exceeding 30%, pose significant challenges in bioequivalence (BE) trials. Their variability stems from complex pharmacokinetics (PK), influenced by genetic polymorphisms in drug-metabolizing enzymes, transporters, and other pathways. These challenges often lead to larger sample sizes and higher costs. Pharmacogenetics, the study of genetic factors influencing drug response, offers a solution by stratifying participants based on genetic profiles to minimize variability. This paper discusses the role of pharmacogenetics in addressing these challenges, emphasizing its potential to optimize trial design, reduce sample sizes, and improve efficiency. Keywords include bioequivalence, pharmacogenetics, highly variable drugs, pharmacokinetics, genetic polymorphisms, and adaptive trial design.

References

Zhang, W., & Reynolds, K. S. (2019). Role of pharmacogenetics in bioequivalence trials for highly variable drugs. Journal of Clinical Pharmacology, 59(8), 945-955.

European Medicines Agency (EMA). (2010). Guideline on the investigation of bioequivalence.

Rodrigues, A. D. (2021). Drug-drug interactions and pharmacogenetics in pharmacokinetics variability. Drug Metabolism and Disposition, 49(3), 279-296.

Cavallari, L. H., et al. (2020). Role of pharmacogenomics in precision medicine: Applications in BE trials. Pharmacogenomics Journal, 20(6), 477-491.

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Published

2024-10-01

How to Cite

[1]
“Pharmacogenetic Perspectives in Improving Pharmacokinetic Profiles for Efficient Bioequivalence Trials with Highly Variable Drugs”, JASRAE, vol. 21, no. 7, pp. 88–90, Oct. 2024, doi: 10.29070/zzfa6m26.

How to Cite

[1]
“Pharmacogenetic Perspectives in Improving Pharmacokinetic Profiles for Efficient Bioequivalence Trials with Highly Variable Drugs”, JASRAE, vol. 21, no. 7, pp. 88–90, Oct. 2024, doi: 10.29070/zzfa6m26.