INTRODUCTION
This guidance describes a basic framework for designing
and conducting PK/PD studies in pregnant women. It provides recommendations to
sponsors on how to assess the influence of pregnancy on the pharmacokinetics (PK),
and where appropriate, the pharmacodynamics (PD) of drugs
or biologic products.[2]
Additionally, this guidance provides recommendations to primary investigators,
clinical researchers, and clinical pharmacologists about issues to consider when
designing and conducting PK studies in pregnant women.
The Agency recommends using this guidance in conjunction
with other FDA and ICH guidances, and pharmacological and clinical literature,
on the design, conduct, and interpretation of pharmacokinetic studies. Because
the conduct of studies in pregnant women requires specialized knowledge in a
variety of areas, investigators designing such studies are encouraged to obtain
advice from experts in fields such as obstetrics, pediatrics, pharmacology,
clinical pharmacology, pharmacometrics, statistics, and other applicable
disciplines.
Although this guidance provides recommendations on when PK studies
in pregnant women are appropriate, it does not address ways to assess efficacy
of a drug in pregnancy or how to assess whether the drug causes adverse
pregnancy or neonatal outcomes.
FDA’s guidance documents, including this
guidance, do not establish legally enforceable responsibilities. Instead,
guidances describe the Agency’s current thinking on a topic and should be viewed
only as recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.
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