R. Madabushi

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

Nina Isoherranen, Rajanikanth Madabushi, Shiew-Mei Huang, 2019, Clinical and translational science.

Population pharmacodynamic model of bronchodilator response to inhaled albuterol in children and adults with asthma.

Hartmut Derendorf, Rajanikanth Madabushi, J. Lima, 2008, Chest.

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study

N. Stockbridge, R. Bies, J. Gobburu, 2014, Journal of Pharmacokinetics and Pharmacodynamics.

Application of Two-Point Assay of Digoxin Serum Concentration in Studying Population Pharmacokinetics in Egyptian Pediatric Patients with Heart Failure: Does It Make Sense?

H. Derendorf, R. Madabushi, E. Desoky, 2005, American journal of therapeutics.

Sorafenib for the treatment of unresectable hepatocellular carcinoma.

R. Pazdur, R. Justice, R. Sridhara, 2009, The oncologist.

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

I. Zineh, A. Terzic, Shiew-Mei Huang, 2021, Clinical pharmacology and therapeutics.

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks

I. Zineh, Shiew-Mei Huang, Elimika Pfuma Fletcher, 2020, Clinical pharmacology and therapeutics.

Clopidogrel, CYP2C19 and proton pump inhibitors: What we know and what it means

S. Hariharan, R. Madabushi, M. Southworth, 2014, Journal of clinical pharmacology.

Roadmap to 2030 for Drug Evaluation in Older Adults

J. Gurwitz, M. Pirmohamed, B. Radziszewska, 2021, Clinical pharmacology and therapeutics.

PHARMACOKINETICS AND DISPOSITION

R. Madabushi, B. Drewelow, B. Frank, 2006 .

Hyperforin in St. John’s wort drug interactions

H. Derendorf, V. Butterweck, R. Madabushi, 2006, European Journal of Clinical Pharmacology.

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

S. Visser, E. Manolis, A. Staab, 2019, CPT: pharmacometrics & systems pharmacology.

Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistance development?

T. Welte, H. Derendorf, Vipul Kumar, 2006, The Journal of antimicrobial chemotherapy.

Dosing Rationale for Liraglutide in Type 2 Diabetes Mellitus: A Pharmacometric Assessment

D. Jonker, S. Ingwersen, C. Tornøe, 2012, Journal of clinical pharmacology.

Model‐Informed Drug Development: A Regulatory Perspective on Progress

D. Strauss, I. Zineh, Shiew-Mei Huang, 2019, Clinical pharmacology and therapeutics.

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

I. Zineh, R. Madabushi, M. Pacanowski, 2019, Clinical and translational science.

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

Liang Zhao, Hao Zhu, R. Madabushi, 2022, Pharmaceutical Research.

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

Yow-Ming C Wang, I. Zineh, Eric Brodsky, 2020, Therapeutic innovation & regulatory science.

Misclassification and discordance of measured blood pressure from patient’s true blood pressure in current clinical practice: a clinical trial simulation case study

N. Stockbridge, R. Bies, J. Gobburu, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

Misclassification and discordance of measured blood pressure from patient’s true blood pressure in current clinical practice: a clinical trial simulation case study

N. Stockbridge, R. Bies, J. Gobburu, 2012, Journal of Pharmacokinetics and Pharmacodynamics.

Development and Validation of an HPLC Method for Oxytocin in Ringer's Lactate and its Application in Stability Analysis

H. Derendorf, R. Hatton, Vipul Kumar, 2006 .

Pharmacokinetics of cefpodoxime in plasma and subcutaneous fluid following oral administration of cefpodoxime proxetil in male beagle dogs.

R. Madabushi, V. Kumar, M. Lucchesi, 2011, Journal of veterinary pharmacology and therapeutics.

Moxifloxacin distribution in the interstitial space of infected decubitus ulcer tissue of patients with spinal cord injury measured by in vivo microdialysis

J. Barth, H. Derendorf, Vipul Kumar, 2006, Scandinavian journal of infectious diseases.

Essential Pharmacokinetic Information for Drug Dosage Decisions: A Concise Visual Presentation in the Drug Label

N. Stockbridge, L. Lesko, R. Uppoor, 2011, Clinical pharmacology and therapeutics.

Extended Stability of Oxytocin in Ringer's Lactate Solution at 4° and 25°C

H. Derendorf, R. Hatton, Vipul Kumar, 2006 .

Clinical Pharmacology Basis of Deriving Dosing Recommendations for Dabigatran in Patients With Severe Renal Impairment

S. Hariharan, R. Madabushi, 2012, Journal of clinical pharmacology.

Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004–2006

Yaning Wang, Lawrence J Lesko, Rajanikanth Madabushi, 2008, Journal of clinical pharmacology.

Concentration‐QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Norman Stockbridge, Yaning Wang, Christine E Garnett, 2008, Journal of clinical pharmacology.

Pharmacokinetic and Pharmacodynamic Basis for Effective Argatroban Dosing in Pediatrics

J. Gobburu, G. Young, B. Patel, 2011, Journal of clinical pharmacology.

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

R. Araojo, K. Vasisht, D. Green, 2022, Clinical pharmacology and therapeutics.

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

R. Madabushi, Xinning Yang, A. Ramamoorthy, 2022, Clinical and translational science.

Regulatory Perspectives on Biomarker Development

J. Woodcock, L. Lesko, R. Madabushi, 2012 .

Predicted impact of various clinical practice strategies on cardiovascular risk for the treatment of hypertension: a clinical trial simulation study

N. Stockbridge, R. Bies, J. Gobburu, 2014, Journal of Pharmacokinetics and Pharmacodynamics.

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.

Norman Stockbridge, Rajanikanth Madabushi, Michael Pacanowski, 2015, Circulation.

Heterogeneity in treatment effects across diverse populations

V. Miller, Barbara Buch, J. Bull, 2021, Pharmaceutical statistics.

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

I. Zineh, D. Gonzalez, Hao Zhu, 2020, Clinical pharmacology and therapeutics.

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

Hao Zhu, Shiew-Mei Huang, Yaning Wang, 2019, Clinical pharmacology and therapeutics.

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

R. Madabushi, Peng Zou, D. Tran, 2023, The AAPS Journal.

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

Justin C. Earp, D. Strauss, J. Bai, 2021, CPT: pharmacometrics & systems pharmacology.

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

Justin C. Earp, Christina M. Friedrich, K. Gadkar, 2021, The AAPS Journal.

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

I. Zineh, Yaning Wang, R. Madabushi, 2019, CPT: pharmacometrics & systems pharmacology.

Transporters in Drug Development: Scientific and Regulatory Considerations

Lei Zhang, Issam Zineh, Rajanikanth Madabushi, 2018, Clinical pharmacology and therapeutics.

Experience in QT evaluation of oncology drug products since ICH E14 guidance

C. Garnett, B. Booth, R. Madabushi, 2008 .

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

Shiew-Mei Huang, K. Reynolds, R. Madabushi, 2022, Clinical pharmacology and therapeutics.

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

Yow-Ming C Wang, I. Zineh, R. Madabushi, 2020, Clinical pharmacology and therapeutics.

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

I. Zineh, Elimika Pfuma Fletcher, R. Madabushi, 2023, Journal of clinical pharmacology.

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

I. Zineh, R. Madabushi, K. Maxfield, 2020, Clinical pharmacology and therapeutics.

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

S. Visser, E. Manolis, A. Staab, 2019, CPT: pharmacometrics & systems pharmacology.

A Holistic and Integrative Approach for Advancing Model‐Informed Drug Development

I. Zineh, Yaning Wang, R. Madabushi, 2019, CPT: pharmacometrics & systems pharmacology.

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

R. Madabushi, J. Vaidyanathan, E. P. Fletcher, 2023, Journal of clinical pharmacology.

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

I. Zineh, Shiew-Mei Huang, R. Madabushi, 2024, Clinical pharmacology and therapeutics.

Hyperforin in St. John’s wort drug interactions

R. Madabushi, B. Frank, Hartmut Derendorf, 2006, European Journal of Clinical Pharmacology.

Moving forward from Cockcroft-Gault creatinine clearance to race-free estimated glomerular filtration rate to improve medication-related decision-making in adults across healthcare settings: A consensus of the National Kidney Foundation Workgroup for Implementation of Race-Free eGFR-Based Medication

Ann M. Philbrick, Joshua J. Neumiller, R. Madabushi, 2024, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.