Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies—A Case Study with Clopidogrel
Year: 2025
Type: article
Language: en
Topic: Statistical Methods in Clinical Trials
Authors and affiliations:
raw_author_name: Mathangi Gopalakrishnan
raw_affiliation_strings: Center for Translational Medicine University of Maryland Baltimore  Baltimore MD USA
Center for Translational Medicine, University of Maryland Baltimore, Baltimore, MD, USA
raw_author_name: Adithya Karthik Bhattiprolu
raw_affiliation_strings: Biopharmaceutics Group Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO)  Hyderabad Telangana India
Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India
raw_author_name: Joga Gobburu
raw_affiliation_strings: Center for Translational Medicine University of Maryland Baltimore  Baltimore MD USA
Center for Translational Medicine, University of Maryland Baltimore, Baltimore, MD, USA
raw_author_name: Rajkumar Boddu
raw_affiliation_strings: Biopharmaceutics Group Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO)  Hyderabad Telangana India
Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India
raw_author_name: Veena Kambam
raw_affiliation_strings: Clinical Pharmacokinetics, Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO) Hyderabad Telangana India
Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India
raw_author_name: Sohel Mohammed Khan
raw_affiliation_strings: Clinical Pharmacokinetics, Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO) Hyderabad Telangana India
Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India
raw_author_name: Anuj Kumar Saini
raw_affiliation_strings: Biopharmaceutics Group Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO)  Hyderabad Telangana India
Clinical Pharmacokinetics, Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO) Hyderabad Telangana India
Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India
raw_author_name: Sivacharan Kollipara
raw_affiliation_strings: Biopharmaceutics Group Global Clinical Management Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO)  Hyderabad Telangana India
Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, Telangana, India