Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Guidelines on Model Fitting and Recommendations on Time Course for In Vitro Cytochrome P450 Induction Studies Including Impact on Drug Interaction Risk Assessment
Simon Wong, Diane Ramsden, Shannon Dallas, Conrad A. Fung, Heidi J. Einolf, Jairam Palamanda, Liangfu Chen, Theunis C. Goosen, Y. Amy Siu, George Zhang, Donald Tweedie, Niresh Hariparsad, Barry Jones, Phillip D. Yates
Topics & Concepts
CYP2B6CYP1A2PharmacologyEnzyme inducerCYP3A4PhenobarbitalEfavirenzBiologyMedicineCytochrome P450BiochemistryImmunologyEnzymeAntiretroviral therapyViral loadHuman immunodeficiency virus (HIV)Pharmacogenetics and Drug MetabolismDrug Transport and Resistance MechanismsStatistical Methods in Clinical Trials