Module232025

FDA Guidance: Exposure-Response Relationships – Study Design, Data Analysis, and Regulatory Applications

FDA Draft Guidance: General clinical pharmacology considerations for pediatric studies for drugs and biological products

Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials

Evaluating the Risks of Drug Exposure in Human Pregnancies

Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format

Geriatric Information in Human Prescription Drug and Biological Product Labeling

Japan guidance The following space on PMDA website provides useful information on paediatrics and orphans drugs and this space provides info on the paediatric WG

UK guidance Procedures for UK paediatric investigation plan (PIPs)

Switzerland guidance Questions and answers on the Paediatric Investigation Plan

The following space on Swissmedic website has a great deal of information and guidance relating to submission of paediatric investigation plans

References Kato reference from Lecture 13

During the module, the Speakers will provide citations to other references which support their specific topic areas and these can be reviewed after the module.