Generalizabilty Probability: Importance in Clinical Research

  • Rada Santosh Kumar GITAM Institute of Pharmacy, GITAM (Deemed to be University)
  • S. Sai Kiran

Abstract

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.

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Author Biographies

Rada Santosh Kumar, GITAM Institute of Pharmacy, GITAM (Deemed to be University)

GITAM Institute of Pharmacy, GITAM (Deemed To Be University) Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India

S. Sai Kiran

GITAM Institute of Pharmacy, GITAM (Deemed To Be University) Rushikonda, Visakhapatnam-530045, Andhra Pradesh, India

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How to Cite
Santosh Kumar, R., & Sai Kiran, S. (2019). Generalizabilty Probability: Importance in Clinical Research. Journal of Drug Delivery and Therapeutics, 9(5-s), 162-163. https://doi.org/10.22270/jddt.v9i5-s.3587

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