Pharmacogenetic Approaches to Optimize Bioequivalence Studies in Generic Drug Development

Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx...

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Veröffentlicht in:	Journal of clinical pharmacology Jg. 65; H. 11; S. 1598 - 1608
Hauptverfasser:	Bae, Jihyun, Shon, Jihong, Kim, Myong‐Jin, Li, Karen
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	England Wiley Subscription Services, Inc 01.11.2025
Schlagworte:	Bioequivalence bioequivalence studies with pharmacokinetic endpoints Cytochrome P450 Drug development Drug Development - methods Drugs, Generic - pharmacokinetics Gene polymorphism generic drug development Generic drugs Genetic variability Humans Information processing Pharmacogenetics - methods pharmacogenetics/pharmacogenomics Pharmacokinetics Pharmacovigilance product‐specific guidances regulatory/scientific affairs Therapeutic Equivalency United States United States Food and Drug Administration United States generic drug development bioequivalence studies with pharmacokinetic endpoints product‐specific guidances pharmacogenetics/pharmacogenomics regulatory/scientific affairs
ISSN:	0091-2700, 1552-4604, 1552-4604
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Abstract	Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx information has been often utilized in new drug development, its use in generic drug development has not been fully considered. To understand the current landscape of its utility in generic drug development, product‐specific guidances (PSGs) from the US Food and Drug Administration (FDA) containing PGx information were reviewed, along with study protocols submitted by generic drug applicants under abbreviated new drug applications (ANDAs) or controlled correspondences for the identified reference listed drugs (RLDs). Fifteen PSGs (15 RLDs) recommended PGx information as a consideration factor for subject population selection, particularly for drugs associated with inherited enzyme deficiencies or cytochrome P450 polymorphism. The PGx‐based considerations in these PSGs aimed to prevent serious adverse events (60%), optimize PK BE study design (7%), or address both factors (33%). Among the 15 RLDs, 5 had submitted ANDAs or correspondences with PK BE study protocols after their respective PSGs were published. Most of these submissions aligned with the PSG recommendations, incorporating PGx‐related exclusion criteria. These findings suggest that while the number of submissions is low, generic drug developers are increasingly integrating PGx considerations in PK BE studies, recognizing its potential to enhance safety and efficiency in generic drug development. Continuing efforts from both regulators and industry are critical to expand its application to other drug candidates.
AbstractList	Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx information has been often utilized in new drug development, its use in generic drug development has not been fully considered. To understand the current landscape of its utility in generic drug development, product-specific guidances (PSGs) from the US Food and Drug Administration (FDA) containing PGx information were reviewed, along with study protocols submitted by generic drug applicants under abbreviated new drug applications (ANDAs) or controlled correspondences for the identified reference listed drugs (RLDs). Fifteen PSGs (15 RLDs) recommended PGx information as a consideration factor for subject population selection, particularly for drugs associated with inherited enzyme deficiencies or cytochrome P450 polymorphism. The PGx-based considerations in these PSGs aimed to prevent serious adverse events (60%), optimize PK BE study design (7%), or address both factors (33%). Among the 15 RLDs, 5 had submitted ANDAs or correspondences with PK BE study protocols after their respective PSGs were published. Most of these submissions aligned with the PSG recommendations, incorporating PGx-related exclusion criteria. These findings suggest that while the number of submissions is low, generic drug developers are increasingly integrating PGx considerations in PK BE studies, recognizing its potential to enhance safety and efficiency in generic drug development. Continuing efforts from both regulators and industry are critical to expand its application to other drug candidates.Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx information has been often utilized in new drug development, its use in generic drug development has not been fully considered. To understand the current landscape of its utility in generic drug development, product-specific guidances (PSGs) from the US Food and Drug Administration (FDA) containing PGx information were reviewed, along with study protocols submitted by generic drug applicants under abbreviated new drug applications (ANDAs) or controlled correspondences for the identified reference listed drugs (RLDs). Fifteen PSGs (15 RLDs) recommended PGx information as a consideration factor for subject population selection, particularly for drugs associated with inherited enzyme deficiencies or cytochrome P450 polymorphism. The PGx-based considerations in these PSGs aimed to prevent serious adverse events (60%), optimize PK BE study design (7%), or address both factors (33%). Among the 15 RLDs, 5 had submitted ANDAs or correspondences with PK BE study protocols after their respective PSGs were published. Most of these submissions aligned with the PSG recommendations, incorporating PGx-related exclusion criteria. These findings suggest that while the number of submissions is low, generic drug developers are increasingly integrating PGx considerations in PK BE studies, recognizing its potential to enhance safety and efficiency in generic drug development. Continuing efforts from both regulators and industry are critical to expand its application to other drug candidates. Given the significant impacts of interindividual genetic variability on drug safety and pharmacokinetics, integrating pharmacogenetic (PGx) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development. While PGx information has been often utilized in new drug development, its use in generic drug development has not been fully considered. To understand the current landscape of its utility in generic drug development, product-specific guidances (PSGs) from the US Food and Drug Administration (FDA) containing PGx information were reviewed, along with study protocols submitted by generic drug applicants under abbreviated new drug applications (ANDAs) or controlled correspondences for the identified reference listed drugs (RLDs). Fifteen PSGs (15 RLDs) recommended PGx information as a consideration factor for subject population selection, particularly for drugs associated with inherited enzyme deficiencies or cytochrome P450 polymorphism. The PGx-based considerations in these PSGs aimed to prevent serious adverse events (60%), optimize PK BE study design (7%), or address both factors (33%). Among the 15 RLDs, 5 had submitted ANDAs or correspondences with PK BE study protocols after their respective PSGs were published. Most of these submissions aligned with the PSG recommendations, incorporating PGx-related exclusion criteria. These findings suggest that while the number of submissions is low, generic drug developers are increasingly integrating PGx considerations in PK BE studies, recognizing its potential to enhance safety and efficiency in generic drug development. Continuing efforts from both regulators and industry are critical to expand its application to other drug candidates.
Author	Shon, Jihong Kim, Myong‐Jin Li, Karen Bae, Jihyun
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Cites_doi	10.1002/cpt.2754 10.3390/jpm11030179 10.1016/j.tig.2003.09.008 10.1371/journal.pone.0146262
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References_xml	– year: 2022 – year: 2021 – year: 2020 – year: 2023 – year: 2024 – volume: 11 start-page: 179 issue: 3 year: 2021 article-title: Pharmacogenomic biomarkers in US FDA‐approved drug labels (2000–2020) publication-title: Journal of Personalized Medicine – volume: 19 start-page: 660 issue: 11 year: 2003 end-page: 666 article-title: Pharmacogenetics: potential for individualized drug therapy through genetics publication-title: Trends in Genetics – volume: 11 issue: 1 year: 2016 article-title: Economic evaluations of pharmacogenetic and pharmacogenomic screening tests: a systematic review. Second update of the literature publication-title: PLoS ONE – year: 2017 – year: 2018 – year: 2019 – volume: 112 start-page: 1318 issue: 6 year: 2022 end-page: 1328 article-title: Cost effectiveness of pharmacogenetic testing for drugs with clinical pharmacogenetics implementation consortium guidelines: a systematic review publication-title: Clinical Pharmacology & Therapeutics – year: 2014 – ident: e_1_2_11_41_1 – ident: e_1_2_11_5_1 – ident: e_1_2_11_16_1 – ident: e_1_2_11_24_1 – ident: e_1_2_11_10_1 – ident: e_1_2_11_39_1 – ident: e_1_2_11_47_1 – ident: e_1_2_11_50_1 doi: 10.1002/cpt.2754 – ident: e_1_2_11_46_1 – ident: e_1_2_11_40_1 – ident: e_1_2_11_32_1 – ident: e_1_2_11_38_1 – ident: e_1_2_11_36_1 doi: 10.3390/jpm11030179 – ident: e_1_2_11_6_1 – ident: e_1_2_11_9_1 – ident: e_1_2_11_28_1 – ident: e_1_2_11_11_1 – ident: e_1_2_11_25_1 – ident: e_1_2_11_33_1 – ident: e_1_2_11_3_1 – ident: e_1_2_11_17_1 – ident: e_1_2_11_14_1 – ident: e_1_2_11_22_1 – ident: e_1_2_11_30_1 – ident: e_1_2_11_13_1 – ident: e_1_2_11_19_1 – ident: e_1_2_11_44_1 – ident: e_1_2_11_21_1 – ident: e_1_2_11_2_1 doi: 10.1016/j.tig.2003.09.008 – ident: e_1_2_11_12_1 – ident: e_1_2_11_27_1 – ident: e_1_2_11_8_1 – ident: e_1_2_11_35_1 – ident: e_1_2_11_43_1 – ident: e_1_2_11_37_1 – ident: e_1_2_11_23_1 – ident: e_1_2_11_48_1 – ident: e_1_2_11_20_1 – ident: e_1_2_11_42_1 – ident: e_1_2_11_45_1 – ident: e_1_2_11_29_1 – ident: e_1_2_11_15_1 – ident: e_1_2_11_26_1 – ident: e_1_2_11_31_1 – ident: e_1_2_11_34_1 – ident: e_1_2_11_4_1 – ident: e_1_2_11_18_1 – ident: e_1_2_11_49_1 doi: 10.1371/journal.pone.0146262 – ident: e_1_2_11_7_1
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SubjectTerms	Bioequivalence bioequivalence studies with pharmacokinetic endpoints Cytochrome P450 Drug development Drug Development - methods Drugs, Generic - pharmacokinetics Gene polymorphism generic drug development Generic drugs Genetic variability Humans Information processing Pharmacogenetics - methods pharmacogenetics/pharmacogenomics Pharmacokinetics Pharmacovigilance product‐specific guidances regulatory/scientific affairs Therapeutic Equivalency United States United States Food and Drug Administration
Title	Pharmacogenetic Approaches to Optimize Bioequivalence Studies in Generic Drug Development
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