Karthik Venkatakrishnan

Publication Activity (10 Years)

Years Active: 2017-2024
Publications (10 Years): 67

Top Topics

Systemic Lupus Erythematosus

Metastatic Colorectal Cancer

Small Cell Lung Cancer

Top Venues

Clinical pharmacology and therapeutics

CPT: pharmacometrics & systems pharmacology

Clinical and translational science

Investigational new drugs

This page only lists publications with an associated author ORCID identifier.

Publications

Michael J Hanley, Steven Zhang, Robert J Griffin, Sean Xiaochun Zhu, Robert J Fram, Jianchang Lin, Karthik Venkatakrishnan, Neeraj Gupta
A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [ 14 C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Investigational new drugs 42 (4) (2024)
Divya Samineni, Karthik Venkatakrishnan, Ahmed A Othman, Yazdi K Pithavala, Srinivasu Poondru, Chirag Patel, Pavan Vaddady, Wendy Ankrom, Saroja Ramanujan, Nageshwar Budha, Michael Wu, Nahor Haddish-Berhane, Holger Fritsch, Azher Hussain, Jitendra Kanodia, Meng Li, Mengyao Li, Murad Melhem, Apurvasena Parikh, Vijay V Upreti, Neeraj Gupta
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper. Clinical pharmacology and therapeutics 116 (3) (2024)
Ping Hu, Haiqing Isaac Dai, James Bourdage, Dongli Zhou, Ky Trang, Karey Kowalski, Carlo Bello, Jennifer E Hibma, Akash Khandelwal, Kyra Cowan, Jennifer Dong, Karthik Venkatakrishnan, Wei Gao
Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma. Clinical and translational science 17 (3) (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. CPT: pharmacometrics & systems pharmacology (2024)
Ana-Marija Milenković-Grišić, Siobhán Hayes, Colm Farrell, Yoshihiro Kuroki, Mauro Bertolino, Karthik Venkatakrishnan, Pascal Girard
Model-informed Evidence for Clinical Non-inferiority of Every-2-Weeks Versus Standard Weekly Dosing Schedule of Cetuximab in Metastatic Colorectal Cancer. Clinical pharmacology and therapeutics (2024)
Michael J Hanley, Steven Zhang, Robert J Griffin, Sean Xiaochun Zhu, Robert J Fram, Jianchang Lin, Karthik Venkatakrishnan, Neeraj Gupta
A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [ 14 C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Investigational new drugs 42 (4) (2024)
Lena Klopp-Schulze, Sathej Gopalakrishnan, Özkan Yalkinoglu, Yoshihiro Kuroki, Hong Lu, Kosalaram Goteti, Axel Krebs-Brown, Marco Nogueira Filho, Ulrike Gradhand, Markus Fluck, Jamie Shaw, Jennifer Dong, Karthik Venkatakrishnan
Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial. Clinical pharmacology and therapeutics (2024)
Ping Hu, Haiqing Isaac Dai, James Bourdage, Dongli Zhou, Ky Trang, Karey Kowalski, Carlo Bello, Jennifer E Hibma, Akash Khandelwal, Kyra Cowan, Jennifer Dong, Karthik Venkatakrishnan, Wei Gao
Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma. Clinical and translational science 17 (3) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology 13 (4) (2024)
Ping Hu, Haiqing Isaac Dai, James Bourdage, Dongli Zhou, Ky Trang, Karey Kowalski, Carlo Bello, Jennifer E Hibma, Akash Khandelwal, Kyra Cowan, Jennifer Dong, Karthik Venkatakrishnan, Wei Gao
Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma. Clinical and translational science 17 (3) (2024)
Nadia Terranova, Karthik Venkatakrishnan
Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model-Informed Precision Medicine. Clinical pharmacology and therapeutics 115 (4) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology 13 (4) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. Clinical and translational science 17 (6) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology 13 (4) (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. CPT: pharmacometrics & systems pharmacology 13 (6) (2024)
Nadia Terranova, Karthik Venkatakrishnan
Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model-Informed Precision Medicine. Clinical pharmacology and therapeutics 115 (4) (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. CPT: pharmacometrics & systems pharmacology 13 (6) (2024)
Nadia Terranova, Karthik Venkatakrishnan
Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model-Informed Precision Medicine. Clinical pharmacology and therapeutics 115 (4) (2024)
Michael J Hanley, Steven Zhang, Robert J Griffin, Sean Xiaochun Zhu, Robert J Fram, Jianchang Lin, Karthik Venkatakrishnan, Neeraj Gupta
A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [ 14 C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Investigational new drugs 42 (4) (2024)
Iris K Minichmayr, Mohamad Shebley, Piet H van der Graaf, Karthik Venkatakrishnan
Getting the Dosage Right: A Vital Role for Clinical Pharmacology in the Era of Precision Medicine. Clinical pharmacology and therapeutics 116 (3) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology 13 (4) (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. Clinical and translational science 17 (6) (2024)
Lena Klopp-Schulze, Sathej Gopalakrishnan, Özkan Yalkinoglu, Yoshihiro Kuroki, Hong Lu, Kosalaram Goteti, Axel Krebs-Brown, Marco Nogueira Filho, Ulrike Gradhand, Markus Fluck, Jamie Shaw, Jennifer Dong, Karthik Venkatakrishnan
Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial. Clinical pharmacology and therapeutics 115 (6) (2024)
Michael J Hanley, Steven Zhang, Robert J Griffin, Sean Xiaochun Zhu, Robert J Fram, Jianchang Lin, Karthik Venkatakrishnan, Neeraj Gupta
A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [ 14 C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants. Investigational new drugs (2024)
Divya Samineni, Karthik Venkatakrishnan, Ahmed A Othman, Yazdi K Pithavala, Srinivasu Poondru, Chirag Patel, Pavan Vaddady, Wendy Ankrom, Saroja Ramanujan, Nageshwar Budha, Michael Wu, Nahor Haddish-Berhane, Holger Fritsch, Azher Hussain, Jitendra Kanodia, Meng Li, Mengyao Li, Murad Melhem, Apurvasena Parikh, Vijay V Upreti, Neeraj Gupta
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper. Clinical pharmacology and therapeutics (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the Needle for Oncology Dose Optimization: A Call for Action. Clinical pharmacology and therapeutics 115 (6) (2024)
Michael J Hanley, Karen Rowland Yeo, Meera Tugnait, Shinji Iwasaki, Narayana Narasimhan, Pingkuan Zhang, Karthik Venkatakrishnan, Neeraj Gupta
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach. CPT: pharmacometrics & systems pharmacology 13 (4) (2024)
Ping Hu, Haiqing Isaac Dai, James Bourdage, Dongli Zhou, Ky Trang, Karey Kowalski, Carlo Bello, Jennifer E Hibma, Akash Khandelwal, Kyra Cowan, Jennifer Dong, Karthik Venkatakrishnan, Wei Gao
Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma. Clinical and translational science 17 (3) (2024)
Karthik Venkatakrishnan, Priya Jayachandran, Shirley K Seo, Piet H van der Graaf, John A Wagner, Neeraj Gupta
Moving the needle for oncology dose optimization: A call for action. CPT: pharmacometrics & systems pharmacology 13 (6) (2024)
Karthik Venkatakrishnan, Karen E Brown, Kathleen M Giacomini, Piet H van der Graaf
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All. Clinical pharmacology and therapeutics 113 (3) (2023)
Nadia Terranova, Karthik Venkatakrishnan
Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model-Informed Precision Medicine. Clinical pharmacology and therapeutics (2023)
Karthik Venkatakrishnan, Karen E Brown, Kathleen M Giacomini, Piet H van der Graaf
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All. Clinical pharmacology and therapeutics 113 (3) (2023)
Kosalaram Goteti, Ramon Garcia, William R Gillespie, Jonathan L French, Lena Klopp-Schulze, Ying Li, Cristina Vazquez Mateo, Sanjeev Roy, Oliver Guenther, Lisa Benincosa, Karthik Venkatakrishnan
Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus. CPT: pharmacometrics & systems pharmacology (2023)
Neeraj Gupta, Michael J Hanley, Robert J Griffin, Pingkuan Zhang, Karthik Venkatakrishnan, Vikram Sinha
Clinical Pharmacology of Brigatinib: A Next-Generation Anaplastic Lymphoma Kinase Inhibitor. Clinical pharmacokinetics (2023)
Michael J Hanley, David Kerstein, Meera Tugnait, Narayana Narasimhan, Thomas C Marbury, Karthik Venkatakrishnan, Neeraj Gupta
Brigatinib pharmacokinetics in patients with chronic hepatic impairment. Investigational new drugs (2023)
Yulia Vugmeyster, Abhigyan Ravula, Elisabeth Rouits, Paul Matthias Diderichsen, Huub Jan Kleijn, Andre Koenig, XiaoZhe Wang, Andreas Schroeder, Kosalaram Goteti, Karthik Venkatakrishnan
Model-informed selection of the recommended phase 3 dose of the inhibitor of apoptosis protein inhibitor, xevinapant, in combination with cisplatin and concurrent radiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck. Clinical pharmacology and therapeutics (2023)
Nadia Terranova, Karthik Venkatakrishnan
Machine Learning in Modeling Disease Trajectory and Treatment Outcomes: An Emerging Enabler for Model-Informed Precision Medicine. Clinical pharmacology and therapeutics (2023)
Karthik Venkatakrishnan, Karen E Brown, Kathleen M Giacomini, Piet H van der Graaf
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All. Clinical pharmacology and therapeutics 113 (3) (2023)
Songmao Zheng, Karthik Venkatakrishnan, Beth Benatti Kennedy
How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model. Clinical and translational science 15 (10) (2022)
Ana-Marija Milenković-Grišić, Karthik Venkatakrishnan, Jonathan L French, Akash Khandelwal
Variable or variate? A conundrum in pharmacometrics exposure-response models. CPT: pharmacometrics & systems pharmacology 12 (2) (2022)
Akash Khandelwal, Ana-Marija Milenković-Grišić, Jonathan L French, Karthik Venkatakrishnan
Pharmacometrics Golems: Exposure-Response Models in Oncology. Clinical pharmacology and therapeutics 112 (5) (2022)
Jayaprakasam Bolleddula, Sathej Gopalakrishnan, Ping Hu, Jennifer Dong, Karthik Venkatakrishnan
Alternatives to rifampicin: A review and perspectives on the choice of strong CYP3A inducers for clinical drug-drug interaction studies. Clinical and translational science 15 (9) (2022)
Neeraj Gupta, Karen L Reckamp, David R Camidge, Huub J Kleijn, Aziz Ouerdani, Francesco Bellanti, John Maringwa, Michael J Hanley, Shining Wang, Pingkuan Zhang, Karthik Venkatakrishnan
Population pharmacokinetic and exposure-response analyses from ALTA-1L: Model-based analyses supporting the brigatinib dose in ALK-positive NSCLC. Clinical and translational science 15 (5) (2022)
Ana-Marija Milenković-Grišić, Karthik Venkatakrishnan, Jonathan L French, Akash Khandelwal
Variable or variate? A conundrum in pharmacometrics exposure-response models. CPT: pharmacometrics & systems pharmacology (2022)
Kosalaram Goteti, Jonathan L French, Ramon Garcia, Ying Li, Florence Casset-Semanaz, Aida Aydemir, Robert Townsend, Cristina Vazquez Mateo, Matthew Studham, Oliver Guenther, Amy Kao, Marc R Gastonguay, Pascal Girard, Lisa Benincosa, Karthik Venkatakrishnan
Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development. CPT: pharmacometrics & systems pharmacology (2022)
Ana-Marija Milenković-Grišić, Karthik Venkatakrishnan, Jonathan L French, Akash Khandelwal
Variable or variate? A conundrum in pharmacometrics exposure-response models. CPT: pharmacometrics & systems pharmacology 12 (2) (2022)
Ana-Marija Milenković-Grišić, Karthik Venkatakrishnan, Jonathan L French, Akash Khandelwal
Variable or variate? A conundrum in pharmacometrics exposure-response models. CPT: pharmacometrics & systems pharmacology 12 (2) (2022)
Karthik Venkatakrishnan, Neeraj Gupta, Patrick F Smith, Tiffany Lin, Neil Lineberry, Tatiana Ishida, Lin Wang, Mark Rogge
Asia-Inclusive Clinical Research and Development Enabled by Translational Science and Quantitative Clinical Pharmacology: Toward a Culture That Challenges the Status Quo. Clinical pharmacology and therapeutics (2022)
Karthik Venkatakrishnan, Piet H van der Graaf
Toward Project Optimus for Oncology Precision Medicine: Multi-Dimensional Dose Optimization Enabled by Quantitative Clinical Pharmacology. Clinical pharmacology and therapeutics 112 (5) (2022)
Yulia Vugmeyster, George Locke, Christoph Helwig, P Alexander Rolfe, Jennifer Q Dong, Karthik Venkatakrishnan
Risk assessment of drug-drug interaction potential for bintrafusp alfa with cytochrome P4503A4 substrates: A totality of evidence approach. Clinical and translational science (2022)
Karthik Venkatakrishnan, Lisa J Benincosa
Diversity and Inclusion in Drug Development: Rethinking Intrinsic and Extrinsic Factors with Patient Centricity. Clinical pharmacology and therapeutics (2021)
Neeraj Gupta, Michael J Hanley, David Kerstein, Meera Tugnait, Narayana Narasimhan, Thomas C Marbury, Karthik Venkatakrishnan
Effect of severe renal impairment on the pharmacokinetics of brigatinib. Investigational new drugs 39 (5) (2021)
Bart S Hendriks, Karthik Venkatakrishnan
Essential (and Largely Untaught) Skills for Clinical Pharmacology in Oncology Drug Development. Clinical pharmacology and therapeutics (2021)
Xiaofei Zhou, Sharon Friedlander, Erik Kupperman, Farhad Sedarati, Shingo Kuroda, Zhaowei Hua, Ying Yuan, Yuka Yamamoto, Douglas V Faller, Kazue Haikawa, Katsuhiko Nakai, Sharon Bowen, Yi Dai, Karthik Venkatakrishnan
Asia-inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial. Clinical and translational science 14 (3) (2021)
Neeraj Gupta, Xiaohui Wang, Elliot Offman, Marita Prohn, Narayana Narasimhan, David Kerstein, Michael J Hanley, Karthik Venkatakrishnan
Population Pharmacokinetics of Brigatinib in Healthy Volunteers and Patients With Cancer. Clinical pharmacokinetics 60 (2) (2021)
Vikram Arya, Karthik Venkatakrishnan
Role of Physiologically Based Pharmacokinetic Modeling and Simulation in Enabling Model-Informed Development of Drugs and Biotherapeutics. Journal of clinical pharmacology (2021)
Karthik Venkatakrishnan, Piet H van der Graaf
Model-Informed Drug Development: Connecting the Dots With a Totality of Evidence Mindset to Advance Therapeutics. Clinical pharmacology and therapeutics 110 (5) (2021)
Ajit Suri, Diane R Mould, Gregory Song, Judith Kinley, Karthik Venkatakrishnan
Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. Journal of clinical pharmacology 60 (12) (2020)
Karen Rowland Yeo, Karthik Venkatakrishnan
Physiologically-Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study. Clinical pharmacology and therapeutics 109 (1) (2020)
Beth B Kennedy, Karthik Venkatakrishnan
Staying Engaged in Your Career Without Burning Out: A Call for Action to Build Resilience. Clinical and translational science 13 (6) (2020)
Karthik Venkatakrishnan, Oezkan Yalkinoglu, Jennifer Q Dong, Lisa J Benincosa
Challenges in Drug Development Posed by the COVID-19 Pandemic: An Opportunity for Clinical Pharmacology. Clinical pharmacology and therapeutics 108 (4) (2020)
Dean Bottino, Rachael Liu, Hojjat Bazzazi, Karthik Venkatakrishnan
Quantitative Translation in Immuno-Oncology Research and Development. Clinical pharmacology and therapeutics 108 (3) (2020)
Hélène M Faessel, John Nemunaitis, Todd M Bauer, A Craig Lockhart, Douglas V Faller, Farhad Sedarati, Xiaofei Zhou, Karthik Venkatakrishnan, R Donald Harvey
Effect of CYP3A inhibitors on the pharmacokinetics of pevonedistat in patients with advanced solid tumours. British journal of clinical pharmacology 85 (7) (2019)
Hélène M Faessel, Diane R Mould, Xiaofei Zhou, Douglas V Faller, Farhad Sedarati, Karthik Venkatakrishnan
Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies. British journal of clinical pharmacology 85 (11) (2019)
Xiaofei Zhou, Diane R Mould, Takatoshi Takubo, Emily Sheldon-Waniga, Dirk Huebner, Ashley Milton, Karthik Venkatakrishnan
Global population pharmacokinetics of the investigational Aurora A kinase inhibitor alisertib in cancer patients: rationale for lower dosage in Asia. British journal of clinical pharmacology 84 (1) (2017)