Generalizabilty Probability: Importance in Clinical Research
Rada Santosh Kumar, Sapkota Kiran · Journal of Drug Delivery and Therapeutics · 2019
International conference on harmonization (ICH) suggested that bridging study is important to extrapolate clinical results. and also us food and drug administration requires Substantial evidences regarding safety. The review explains about different approaches that are necessary for obtaining clinical results, various clinical results were performed between similar patient population within same or different regions. moreover no criteria on the evaluation of similarity of clinical results between regions is given .It is important in regulatory submission of new drug application .Mainly this review explains about how clinical results are reproducible. Keywords: ICH, Generalizability, probability Reproducibility, clinical trails, bridging study.