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PI‐66
Author(s) -
Nallani S. C.,
Coles L. D.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.087
Subject(s) - pharmacokinetics , lactation , pregnancy , medicine , clinical pharmacology , pharmacology , obstetrics , intensive care medicine , biology , genetics
BACKGROUND Providing pregnant and lactating women with the benefits of scientific evidence‐based treatment is an unmet medical need. We attempted to derive meaningful clinical pharmacology, dosage adjustment information for drugs used in pregnancy and lactation. METHODS Regulatory submissions and public domain literature were searched for information on pharmacokinetics and pharmacodynamics of parent drug and metabolite(s) during pregnancy and lactation. Data were critically reviewed with regard to the analytical method validation, pharmacokinetic and statistical data analysis methods, validity of pharmacodynamic endpoints, adverse event reports in pregnant and lactating women. RESULTS A searchable clinical pharmacokinetics database was created consisting of over 450 published articles and over 50 product labels. The drug classes evaluated include antiepileptic, antidepressant, cardiovascular, antiretroviral, and anesthetic and analgesic agents. Changes in absorption, distribution, and elimination were noted for several drugs used during pregnancy. Data were summarized with emphasis on specific mechanistic changes in ADME that occur during pregnancy. CONCLUSIONS A clinical pharmacokinetics database has been created and the information is being used to improve the “Pregnancy” Section of several product labels. It is also a convenient aide for the FDA reviewers in providing quick access to clinical pharmacokinetics data for specific drugs used in pregnancy. Clinical Pharmacology & Therapeutics (2005) 79 , P24–P24; doi: 10.1016/j.clpt.2005.12.087