Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

Mark Donnelly; Eleftheria Tsakalozou; Satish Sharan; Thomas Straubinger; Robert Bies; Liang Zhao

doi:10.1002/jcph.1760

Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

Mark Donnelly
, Eleftheria Tsakalozou
, Satish Sharan
, Thomas Straubinger
, Robert Bies
, Liang Zhao

Pharmaceutical Sciences

United States Food and Drug Administration
SUNY Buffalo

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Original language	English
Pages (from-to)	S26-S33
Journal	Journal of Clinical Pharmacology
Volume	60
Issue number	S2
DOIs	https://doi.org/10.1002/jcph.1760
State	Published - Dec 2020

Keywords

bioequivalence
drug delivery
generic drug
intrauterine
physiologically based pharmacokinetics (PBPK)
vaginal

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10.1002/jcph.1760

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Donnelly, M., Tsakalozou, E., Sharan, S., Straubinger, T., Bies, R., & Zhao, L. (2020). Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions. Journal of Clinical Pharmacology, 60(S2), S26-S33. https://doi.org/10.1002/jcph.1760

Donnelly, Mark ; Tsakalozou, Eleftheria ; Sharan, Satish et al. / Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract : The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions. In: Journal of Clinical Pharmacology. 2020 ; Vol. 60, No. S2. pp. S26-S33.

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keywords = "bioequivalence, drug delivery, generic drug, intrauterine, physiologically based pharmacokinetics (PBPK), vaginal",

author = "Mark Donnelly and Eleftheria Tsakalozou and Satish Sharan and Thomas Straubinger and Robert Bies and Liang Zhao",

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Donnelly, M, Tsakalozou, E, Sharan, S, Straubinger, T, Bies, R & Zhao, L 2020, 'Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions', Journal of Clinical Pharmacology, vol. 60, no. S2, pp. S26-S33. https://doi.org/10.1002/jcph.1760

Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions. / Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish et al.
In: Journal of Clinical Pharmacology, Vol. 60, No. S2, 12.2020, p. S26-S33.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract

T2 - The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

AU - Donnelly, Mark

AU - Tsakalozou, Eleftheria

AU - Sharan, Satish

AU - Straubinger, Thomas

AU - Bies, Robert

AU - Zhao, Liang

PY - 2020/12

Y1 - 2020/12

KW - bioequivalence

KW - drug delivery

KW - generic drug

KW - intrauterine

KW - physiologically based pharmacokinetics (PBPK)

KW - vaginal

UR - https://www.scopus.com/pages/publications/85097120667

U2 - 10.1002/jcph.1760

DO - 10.1002/jcph.1760

M3 - Article

C2 - 33274513

AN - SCOPUS:85097120667

SN - 0091-2700

VL - 60

SP - S26-S33

JO - Journal of Clinical Pharmacology

JF - Journal of Clinical Pharmacology

IS - S2

ER -

Donnelly M, Tsakalozou E, Sharan S, Straubinger T, Bies R, Zhao L. Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions. Journal of Clinical Pharmacology. 2020 Dec;60(S2):S26-S33. doi: 10.1002/jcph.1760

Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

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