Publications by authors named "Rajkumar Boddu"

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Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.
Mathangi Gopalakrishnan, Adithya Karthik Bhattiprolu, Joga Gobburu, Rajkumar Boddu, Veena Kambam

J Clin Pharmacol· January 2026

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Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges.
Rajkumar Boddu, Arvind Rachapally, Mohammed Shareef Khan, Sohel Mohammed Khan, Frederico S Martins

Ther Innov Regul Sci· November 2025

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Demonstration of discriminatory power and prediction of behaviour of complex liposomal injectable formulation using physiologically based pharmacokinetic modeling.
Rajkumar Boddu, Maddukuri Harika, Vaneet Munjal, Sivacharan Kollipara

J Liposome Res· October 2025

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Dissolution Profiles Comparison Using Various Model Independent Statistical Approaches: Can We Increase Chance of Similarity?
Rajkumar Boddu, Karthik Parsa, Priyansh Pandya, Sivacharan Kollipara

Pharm Res· August 2025

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New era in bioequivalence global harmonization through ICH M13 initiative: critical review on new concepts, alternative approaches for high-risk products.
Mohammed Shareef Khan, Sohel Mohammed Khan, Frederico Severino Martins, Rajkumar Boddu, Anuj Kumar Saini

Xenobiotica· June 2025

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Bioequivalence requirements for orally inhaled and nasal drug products and use of novel physiologically based biopharmaceutics modeling approaches for assessing in vivo performance.
Aravind Rachapally, Rajkumar Boddu, Sivacharan Kollipara, Tausif Ahmed

J Pharm Sci· February 2025

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Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling.
Adithya Karthik Bhattiprolu, Sivacharan Kollipara, Rajkumar Boddu, Tausif Ahmed

Xenobiotica· October 2024

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Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development.
Rajkumar Boddu, Sivacharan Kollipara, Veena Kambam, Sohel Mohammed Khan, Soumyajit Behera

Xenobiotica· September 2024

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A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation.
Adithya Karthik Bhattiprolu, Sivacharan Kollipara, Rajkumar Boddu, Anand Arumugam, Sohel Mohammed Khan

AAPS PharmSciTech· August 2024

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Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?
Sivacharan Kollipara, Mahendra Chougule, Rajkumar Boddu, Ashima Bhatia, Tausif Ahmed

AAPS J· June 2024

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Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics - a case study and utility in regulatory justifications.
Rajkumar Boddu, Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Tausif Ahmed

Xenobiotica· December 2023

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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.
Rajkumar Boddu, Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Karthik Parsa, Sanketh Kumar Chakilam

AAPS PharmSciTech· December 2023

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Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.
Tausif Ahmed, Sivacharan Kollipara, Rajkumar Boddu, Adithya Karthik Bhattiprolu

AAPS J· July 2023

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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 Boddu, Sivacharan Kollipara, Gautam Vijaywargi, Tausif Ahmed

Xenobiotica· April 2023

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Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective.
Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Rajkumar Boddu, Tausif Ahmed, Siddharth Chachad

AAPS PharmSciTech· February 2023

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Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space.
Adithya Karthik Bhattiprolu, Sivacharan Kollipara, Tausif Ahmed, Rajkumar Boddu, Siddharth Chachad

J Pharm Sci· December 2022

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Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development.
Sivacharan Kollipara, Rajkumar Boddu, Tausif Ahmed, Siddharth Chachad

AAPS PharmSciTech· January 2022

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Development of an Correlation for Sitagliptin and Metformin Prolonged-release Tablet Formulations.
Rajkumar Boddu, Harikiran Chary Vadla, Vamshi Ramana Prathap, Umamaheshwar Kothamasu, Balaramesha Chary Rallabandi

Turk J Pharm Sci· April 2021

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Dissolution studies and quantification of meloxicam in tablet dosage form by spectrophotometry.
Madhusudhanareddy Induri, Bhagavan Raju Mantripragada, Rajendra Prasad Yejella, Pavankumar Reddy Kunda, Dharma Theja Nannapaneni, Rajkumar Boddu

Pak J Pharm Sci· January 2012

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