Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically-Based Pharmacokinetic Modeling: A Regulatory Perspective

被引:8
作者
Cole, Susan [1 ]
Coppola, Paola [1 ]
Kerwash, Essam [1 ]
Nooney, Janet [1 ]
Lam, Siu Ping [1 ]
机构
[1] Med & Healthcare Prod Regulatory Agcy, London, England
来源
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2020年 / 9卷 / 10期
关键词
DRUGS; WOMEN;
D O I
10.1002/psp4.12551
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
[No abstract available]
引用
收藏
页码:547 / 549
页数:3
相关论文
共 10 条
  • [1] Physiologically Based Pharmacokinetic Modeling in Pregnancy: A Systematic Review of Published Models
    Dallmann, Andre
    Pfister, Marc
    van den Anker, John
    Eissing, Thomas
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2018, 104 (06) : 1110 - 1124
  • [2] European Medicine Agency, 2018, EMA1897242018
  • [3] European Medicines Agency, 2005, EMEACHMP3136662005
  • [4] Pharmacokinetics of drugs in pregnancy
    Feghali, Maisa
    Venkataramanan, Raman
    Caritis, Steve
    [J]. SEMINARS IN PERINATOLOGY, 2015, 39 (07) : 512 - 519
  • [5] A PBPK Model to Predict Disposition of CYP3A-Metabolized Drugs in Pregnant Women: Verification and Discerning the Site of CYP3A Induction
    Ke, A. B.
    Nallani, S. C.
    Zhao, P.
    Rostami-Hodjegan, A.
    Unadkat, J. D.
    [J]. CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2012, 1 (09):
  • [6] Drug Dosing in Pregnant Women: Challenges and Opportunities in Using Physiologically Based Pharmacokinetic Modeling and Simulations
    Ke, Alice Ban
    Greupink, Rick
    Abduljalil, Khaled
    [J]. CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2018, 7 (02): : 103 - 110
  • [7] Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19
    Ke, Alice Ban
    Nallani, Srikanth C.
    Zhao, Ping
    Rostami-Hodjegan, Amin
    Unadkat, Jashvant D.
    [J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2014, 77 (03) : 554 - 570
  • [8] Lupattelli A, 2014, BMJ Open, V4, pe004365, DOI [10.1136/bmjopen-2014-005190, 10.1136/bmjopen-2013-004365]
  • [9] The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
    Manolis, E.
    Rohou, S.
    Hemmings, R.
    Salmonson, T.
    Karlsson, M.
    Milligan, P. A.
    [J]. CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2013, 2 (02):
  • [10] US Food and Drug Administration, 2018, Pregnant women: scientific and ethical considerations for inclusion in clinical trials