Drug‐Drug Interaction Studies With Oral Contraceptives: Pharmacokinetic/Pharmacodynamic and Study Design Considerations

Author:

Sun Haiying1,Sivasubramanian Rama2,Vaidya Soniya3,Barve Avantika4,Jarugula Venkateswar1

Affiliation:

1. Novartis Institutes for BioMedical Research East Hanover New Jersey USA

2. Novartis Healthcare Pvt. Ltd. Hyderabad Telangana India

3. Current affiliation: Axcella Health Inc. Cambridge Massachusetts USA

4. Novartis Pharma East Hanover New Jersey USA

Funder

Novartis Pharma

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference118 articles.

1. National Center for Health Statistics.https://www.cdc.gov/nchs/fastats/contraceptive.htm. Published2019. Accessed February 17 2020.

2. United Nations Department of Economic and Social Affairs.https://www.un.org/development/desa/pd/sites/www.un.org.development.desa.pd/files/files/documents/2020/Jan/un_2019_contraceptiveusebymethod_databooklet.pdf. Accessed October 16 2020.

3. EMA. ICH guideline M3(R2) on non‐clinical safety studies for theconduct of human clinical trials and marketing authorisation for pharmaceuticals.https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m3r2-non-clinical-safety-studies-conduct-human-clinical-trials-marketing-authorisation_en.pdf. Published 2009. Accessed September 15 2020.

4. FDA Public Meeting Report on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications”

5. Teratogenic drugs and their drug interactions with hormonal contraceptives

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