Rajanikanth Madabushi

Affiliations

Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA.

Publications (30)

Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.

Therapeutic innovation & regulatory science

Avec: Daphne Guinn , Yow-Ming Wang , Eric Brodsky , Issam Zineh , Kimberly Maxfield

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration-Approved Drugs.

Clinical and translational science

Avec: Robert N Schuck , Michael Pacanowski , Sarah Kim , Issam Zineh

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments.

Clinical pharmacology and therapeutics

Avec: Daphne Guinn , Yow-Ming Wang , Issam Zineh , Kimberly Maxfield

Model-Informed Drug Development: Current US Regulatory Practice and Future Considerations.

Clinical pharmacology and therapeutics

Avec: Yaning Wang , Hao Zhu , Qi Liu , Shiew-Mei Huang , Issam Zineh

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.

CPT: pharmacometrics & systems pharmacology

Avec: Jane P F Bai , Justin C Earp , Jeffry Florian , David G Strauss , Yaning Wang , Hao Zhu

Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.

Clinical pharmacology and therapeutics

Avec: Martina D Sahre , Lauren Milligan , Richard A Graham , Kellie S Reynolds , Andre Terzic , Jessica Benjamin , Gilbert J Burckart , Shiew-Mei Huang , Robert Schuck , Aliza M Thompson , Issam Zineh

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.

The AAPS journal

Avec: Jane P F Bai , Brian J Schmidt , Kapil G Gadkar , Valeriu Damian , Justin C Earp , Christina Friedrich , Piet H van der Graaf , Cynthia J Musante , Kunal Naik , Mark Rogge , Hao Zhu

Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities.

Journal of clinical pharmacology

Avec: Jayabharathi Vaidyanathan , Elimika Pfuma Fletcher , Anuradha Ramamoorthy , Gilbert J Burckart

Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.

Clinical and translational science

Avec: Gelareh A Abulwerdi , Anuradha Ramamoorthy , Edward Bashaw , Gilbert J Burckart , Elimika Pfuma Fletcher

Model-Informed Drug Development-Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non-Radiographic Axial Spondyloarthritis.

Clinical pharmacology and therapeutics

Avec: Dipak S Pisal , Yangbing Li , Amit Golding , Raj Nair , Nikolay P Nikolov , Hao Zhu , Suresh Doddapaneni , Chandrahas Sahajwalla , Youwei Bi , Jianmeng Chen

Heterogeneity in treatment effects across diverse populations.

Pharmaceutical statistics

Avec: Bridget M Nugent , Barbara Buch , Vasum Peiris , Victor Crentsil , Virginia M Miller , Jonca Bull , Marjorie R Jenkins

Roadmap to 2030 for Drug Evaluation in Older Adults.

Clinical pharmacology and therapeutics

Avec: Qi Liu , Janice B Schwartz , Patricia W Slattum , S W Johnny Lau , Daphne Guinn , Gilbert Burckart , Robert Califf , Francesca Cerreta , Carolyn Cho , Jack Cook , Jamie Gamerman , Paul Goldsmith , Piet H van der Graaf , Jerry H Gurwitz , Sebastian Haertter , Sarah Hilmer , Shiew-Mei Huang , Sharon K Inouye , Bindu Kanapuru , Munir Pirmohamed , Phil Posner , Barbara Radziszewska , H Keipp Talbot , Robert Temple

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response-Guided Titration.

Clinical pharmacology and therapeutics

Avec: Lingshan Wang , Kimberly Maxfield , Daphne Guinn , Issam Zineh , Robert N Schuck

Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.

Clinical pharmacology and therapeutics

Avec: Anuradha Ramamoorthy , Richardae Araojo , Kaveeta P Vasisht , Mathilda Fienkeng , Dionna J Green ,

US FDA Postmarketing Requirements and Commitments: A Systematic Assessment of Clinical Pharmacology Studies and Their Impact on US FDA Prescribing Information.

Journal of clinical pharmacology

Avec: Sarah Ridge , Daphne Guinn , Elimika Pfuma Fletcher , Issam Zineh , Anuradha Ramamoorthy

Need for Representation of Pediatric Patients with Obesity in Clinical Trials.

Children (Basel, Switzerland)

Avec: Sherbet Samuels , Jayabharathi Vaidyanathan , Elimika Pfuma Fletcher , Anuradha Ramamoorthy , Gilbert J Burckart

Emerging Role of Organ-on-a-Chip Technologies in Quantitative Clinical Pharmacology Evaluation.

Clinical and translational science

Avec: Nina Isoherranen , Shiew-Mei Huang

Liver Microphysiological Systems for Predicting and Evaluating Drug Effects.

Clinical pharmacology and therapeutics

Avec: Alexandre J S Ribeiro , Xinning Yang , Vikram Patel , Rajnikanth Madabushi , David G Strauss

Comparative Evaluation of Efficacy of Fluoroscopy and Ultrasound for Iliopsoas Block: A Randomised Trial.

Turkish journal of anaesthesiology and reanimation

Avec: Chetna Shamshery , Vijayakumar Vissnu Kumar , Anil Agarwal , Aakanksha Aggarwal , Rajashree Madabushi

Current Perspective on Residual Knowledge Gaps in the Assessment of Transporter-Mediated Drug Interactions.

Clinical pharmacology and therapeutics

Avec: Xinning Yang , Kellie Reynolds , Shiew-Mei Huang

Predicting Food Effects on Oral Extended-Release Drug Products: A Retrospective Evaluation.

The AAPS journal

Avec: Peng Zou , Jayabharathi Vaidyanathan , Doanh Tran , Kimberly Raines , Parnali Chatterjee , Shirley K Seo

Addressing Drug-Drug Interaction Knowledge Gaps at the Time of Approval: An Analysis of FDA Postmarketing Requirements and Commitments from 2009 to 2023.

Journal of clinical pharmacology

Avec: Sarah Ridge , Xinning Yang , Anuradha Ramamoorthy

Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives.

CPT: pharmacometrics & systems pharmacology

Avec: Scott Marshall , Efthymios Manolis , Kevin Krudys , Alexander Staab , Kevin Dykstra , Sandra A G Visser

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.

Pharmaceutical research

Avec: Paul Seo , Liang Zhao , Million Tegenge , Hao Zhu

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non-orphan drugs approved by the FDA.

Clinical and translational science

Avec: Julie Hsieh , Martina Sahre , Xinning Yang , Anuradha Ramamoorthy

Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol.

Journal of clinical pharmacology

Avec: Michelle A Pressly , Stephan Schmidt , Daphne Guinn , Zhichao Liu , Carrie Ceresa , Sherbet Samuels , Jeffry Florian , Elimika Pfuma Fletcher

Statin Drug-Drug Interactions: Pharmacokinetic Basis of FDA Labeling Recommendations and Comparison Across Common Tertiary Clinical Resources.

Journal of clinical pharmacology

Avec: James Mease , Anuradha Ramamoorthy , Xinning Yang , Elimika Pfuma Fletcher , Issam Zineh

Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins.

Clinical pharmacology and therapeutics

Avec: Yow-Ming C Wang , Ping Ji , Sudarshan Hariharan , Jie Wang , Olanrewaju Okusanya , Bilal AbuAsal , Hao Zhu , Shiew Mei Huang , Issam Zineh

Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions.

Journal of clinical pharmacology

Avec: Vishnu Dutt Sharma , Venkatesh Atul Bhattaram , Kevin Krudys , Zhihua Li , Anshu Marathe , Nitin Mehrotra , Xiaofeng Wang , Jiang Liu , Ethan Stier , Jeffry Florian , Raj Madabushi , Hao Zhu

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making.

Clinical pharmacology and therapeutics

Avec: Mary Summer Starling , Lindsay Kehoe , Bruce K Burnett , Phil Green , Karthik Venkatakrishnan ,

Réseau de co-auteurs

Issam Zineh 9 collaborations

Anuradha Ramamoorthy 8 collaborations

Hao Zhu 7 collaborations

Daphne Guinn 6 collaborations

Elimika Pfuma Fletcher 6 collaborations

Shiew-Mei Huang 5 collaborations

Xinning Yang 5 collaborations

Gilbert J Burckart 4 collaborations

Kimberly Maxfield 3 collaborations

Jeffry Florian 3 collaborations

Jayabharathi Vaidyanathan 3 collaborations

Yow-Ming Wang 2 collaborations

Robert N Schuck 2 collaborations

Yaning Wang 2 collaborations

Qi Liu 2 collaborations

Jane P F Bai 2 collaborations

Justin C Earp 2 collaborations

David G Strauss 2 collaborations

Piet H van der Graaf 2 collaborations

Sarah Ridge 2 collaborations

Sherbet Samuels 2 collaborations

Kevin Krudys 2 collaborations

Eric Brodsky 1 collaboration

Michael Pacanowski 1 collaboration

Sarah Kim 1 collaboration

Martina D Sahre 1 collaboration

Lauren Milligan 1 collaboration

Richard A Graham 1 collaboration

Kellie S Reynolds 1 collaboration

Andre Terzic 1 collaboration

Jessica Benjamin 1 collaboration

Robert Schuck 1 collaboration

Aliza M Thompson 1 collaboration

Brian J Schmidt 1 collaboration

Kapil G Gadkar 1 collaboration

Valeriu Damian 1 collaboration

Christina Friedrich 1 collaboration

Cynthia J Musante 1 collaboration

Kunal Naik 1 collaboration

Mark Rogge 1 collaboration

Gelareh A Abulwerdi 1 collaboration

Edward Bashaw 1 collaboration

Dipak S Pisal 1 collaboration

Yangbing Li 1 collaboration

Amit Golding 1 collaboration

Raj Nair 1 collaboration

Nikolay P Nikolov 1 collaboration

Suresh Doddapaneni 1 collaboration

Chandrahas Sahajwalla 1 collaboration

Youwei Bi 1 collaboration

Jianmeng Chen 1 collaboration

Bridget M Nugent 1 collaboration

Barbara Buch 1 collaboration

Vasum Peiris 1 collaboration

Victor Crentsil 1 collaboration

Virginia M Miller 1 collaboration

Jonca Bull 1 collaboration

Marjorie R Jenkins 1 collaboration

Janice B Schwartz 1 collaboration

Patricia W Slattum 1 collaboration

S W Johnny Lau 1 collaboration

Gilbert Burckart 1 collaboration

Robert Califf 1 collaboration

Francesca Cerreta 1 collaboration

Carolyn Cho 1 collaboration

Jack Cook 1 collaboration

Jamie Gamerman 1 collaboration

Paul Goldsmith 1 collaboration

Jerry H Gurwitz 1 collaboration

Sebastian Haertter 1 collaboration

Sarah Hilmer 1 collaboration

Sharon K Inouye 1 collaboration

Bindu Kanapuru 1 collaboration

Munir Pirmohamed 1 collaboration

Phil Posner 1 collaboration

Barbara Radziszewska 1 collaboration

H Keipp Talbot 1 collaboration

Robert Temple 1 collaboration

Lingshan Wang 1 collaboration

Richardae Araojo 1 collaboration

Kaveeta P Vasisht 1 collaboration

Mathilda Fienkeng 1 collaboration

Dionna J Green 1 collaboration

Nina Isoherranen 1 collaboration

Alexandre J S Ribeiro 1 collaboration

Vikram Patel 1 collaboration

Rajnikanth Madabushi 1 collaboration

Chetna Shamshery 1 collaboration

Vijayakumar Vissnu Kumar 1 collaboration

Anil Agarwal 1 collaboration

Aakanksha Aggarwal 1 collaboration

Rajashree Madabushi 1 collaboration

Kellie Reynolds 1 collaboration

Peng Zou 1 collaboration

Doanh Tran 1 collaboration

Kimberly Raines 1 collaboration

Parnali Chatterjee 1 collaboration

Shirley K Seo 1 collaboration

Scott Marshall 1 collaboration

Efthymios Manolis 1 collaboration

Alexander Staab 1 collaboration

Kevin Dykstra 1 collaboration

Sandra A G Visser 1 collaboration

Paul Seo 1 collaboration

Liang Zhao 1 collaboration

Million Tegenge 1 collaboration

Julie Hsieh 1 collaboration

Martina Sahre 1 collaboration

Michelle A Pressly 1 collaboration

Stephan Schmidt 1 collaboration

Zhichao Liu 1 collaboration

Carrie Ceresa 1 collaboration

James Mease 1 collaboration

Yow-Ming C Wang 1 collaboration

Ping Ji 1 collaboration

Sudarshan Hariharan 1 collaboration

Jie Wang 1 collaboration

Olanrewaju Okusanya 1 collaboration

Bilal AbuAsal 1 collaboration

Shiew Mei Huang 1 collaboration

Vishnu Dutt Sharma 1 collaboration

Venkatesh Atul Bhattaram 1 collaboration

Zhihua Li 1 collaboration

Anshu Marathe 1 collaboration

Nitin Mehrotra 1 collaboration

Xiaofeng Wang 1 collaboration

Jiang Liu 1 collaboration

Ethan Stier 1 collaboration

Raj Madabushi 1 collaboration

Mary Summer Starling 1 collaboration

Lindsay Kehoe 1 collaboration

Bruce K Burnett 1 collaboration

Phil Green 1 collaboration

Karthik Venkatakrishnan 1 collaboration