Can I read Pharmacokinetics in Pregnancy Guidance on EtoBox?
Pharmacokinetics in Pregnancy Guidance by Diannisa Afi Solikhah is a document available to read on EtoBox.
What is Pharmacokinetics in Pregnancy Guidance about?
This draft guidance provides recommendations for designing and conducting pharmacokinetic studies in pregnant women to assess how pregnancy affects the pharmacokinetics and pharmacodynamics of drugs. It addresses deciding whether to conduct such studies, study design considerations, data analysis, and impact on drug labeling. The guidance is intended to assist sponsors, investigators, and clinical researchers in areas such as determining dosage recommendations and precautions related to use during pregnancy
- Author
- Diannisa Afi Solikhah
- Language
- EN