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Xenobiotica
the fate of foreign compounds in biological systems
Volume 53, 2023 - Issue 4
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Animal Pharmacokinetics and Metabolism

Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

Rajkumar BodduBiopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, IndiaView further author information
,
Sivacharan KolliparaBiopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, IndiaView further author information
,
Gautam VijaywargiBiopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, IndiaView further author information
&
Tausif AhmedBiopharmaceutics Group, Global Clinical Management, Dr. Reddy’s Laboratories Ltd., Integrated Product Development Organization (IPDO), Hyderabad, IndiaCorrespondence[email protected]
View further author information
Pages 260-278 | Received 21 Jun 2023, Accepted 14 Jul 2023, Published online: 25 Jul 2023

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Rajkumar Boddu, Sivacharan Kollipara, Adithya Karthik Bhattiprolu & Tausif Ahmed. (2023) Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications. Xenobiotica 53:10-11, pages 587-602.
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Rajkumar Boddu, Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Karthik Parsa, Sanketh Kumar Chakilam, Krishna Reddy Daka, Ashima Bhatia & Tausif Ahmed. (2023) Dissolution Profiles Comparison Using Conventional and Bias Corrected and Accelerated f2 Bootstrap Approaches with Different Software’s: Impact of Variability, Sample Size and Number of Bootstraps. AAPS PharmSciTech 25:1.
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