Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels

• Published in: Clinical pharmacology and therapeutics Vol. 113; no. 2; pp. 226 - 245
• Main Authors: Bowman, Christopher J., Becourt‐Lhote, Nathalie, Boulifard, Virginie, Cordts, Rüdiger, Corriol‐Rohou, Solange, Enright, Brian, Erkman, Linda, Harris, Jayne, Hartmann, Andreas, Hilpert, Jan, Kervyn, Sophie, Mattson, Britta, Morford, LaRonda, Muller, Mireille, Powell, Marcy, Sobol, Zhanna, Srinivasan, Rajamuthu, Stark, Claudia, Thompson, Kary E., Turner, Katie J., Barrow, Paul
• Format: Journal Article
• Language: English
• Published: United States 01.02.2023
• Subjects: Consensus; Contraception - adverse effects; Drug Industry; Female; Humans; Male; No-Observed-Adverse-Effect Level; Pharmaceutical Preparations; Pregnancy

This review presents a European Federation of Pharmaceutical Industries and Association/PreClinical Development Expert Group (EFPIA‐PDEG) topic group consensus on a data‐driven approach to harmonized contraception recommendations for clinical trial protocols and product labeling. There is no interna...