Mayawala K - Search Results

1

Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.

Leach MW, Clarke DO, Dudal S, Han C, Li C, Yang Z, Brennan FR, Bailey WJ, Chen Y, Deslandes A, Loberg LI, Mayawala K, Rogge MC, Todd M, Chemuturi NV. Leach MW, et al. Among authors: mayawala k. Clin Pharmacol Ther. 2021 Jun;109(6):1395-1415. doi: 10.1002/cpt.2009. Epub 2020 Nov 3. Clin Pharmacol Ther. 2021. PMID: 32757299

2

Dose Finding Versus Speed in Seamless Immuno-Oncology Drug Development.

Mayawala K, Tse A, Rubin EH, Jain L, de Alwis DP. Mayawala K, et al. J Clin Pharmacol. 2017 Oct;57 Suppl 10:S143-S145. doi: 10.1002/jcph.1001. J Clin Pharmacol. 2017. PMID: 28921649 No abstract available.

3

Experimental Medicine Study to Measure Immune Checkpoint Receptors PD-1 and GITR Turnover Rates In Vivo in Humans.

Lassman ME, Chappell DL, McAvoy T, Cheng A, de Alwis DP, Pruitt SK, Laterza OF, Li C, Stoch A, Mayawala K. Lassman ME, et al. Among authors: mayawala k. Clin Pharmacol Ther. 2021 Jun;109(6):1575-1582. doi: 10.1002/cpt.2129. Epub 2021 Feb 1. Clin Pharmacol Ther. 2021. PMID: 33280089 Clinical Trial.

4

Pivotal Dose of Pembrolizumab: A Dose-Finding Strategy for Immuno-Oncology.

Li TR, Chatterjee M, Lala M, Abraham AK, Freshwater T, Jain L, Sinha V, de Alwis DP, Mayawala K. Li TR, et al. Among authors: mayawala k. Clin Pharmacol Ther. 2021 Jul;110(1):200-209. doi: 10.1002/cpt.2170. Epub 2021 Mar 8. Clin Pharmacol Ther. 2021. PMID: 33462831

5

Mechanistic Basis for Maximally Efficacious Dose of Pembrolizumab.

Mayawala K, Nayak T, Jain L, de Alwis D. Mayawala K, et al. Clin Pharmacol Ther. 2022 May;111(5):994. doi: 10.1002/cpt.2492. Epub 2021 Dec 3. Clin Pharmacol Ther. 2022. PMID: 34859427 No abstract available.

6

Assessment of Clinical Response to V937 Oncolytic Virus After Intravenous or Intratumoral Administration Using Physiologically-Based Modeling.

Parra-Guillen ZP, Sancho-Araiz A, Mayawala K, Zalba S, Garrido MJ, de Alwis D, Troconiz IF, Freshwater T. Parra-Guillen ZP, et al. Among authors: mayawala k. Clin Pharmacol Ther. 2023 Sep;114(3):623-632. doi: 10.1002/cpt.2937. Epub 2023 Jun 2. Clin Pharmacol Ther. 2023. PMID: 37170933

7

Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example.

Sachs JR, Mayawala K, Gadamsetty S, Kang SP, de Alwis DP. Sachs JR, et al. Among authors: mayawala k. Clin Cancer Res. 2016 Mar 15;22(6):1318-24. doi: 10.1158/1078-0432.CCR-15-1295. Epub 2015 Nov 23. Clin Cancer Res. 2016. PMID: 26597302 Review.

8

Model Informed Drug Development: Novel Oncology Agents are Lost in Translation.

Mayawala K, de Alwis DP, Sachs JR. Mayawala K, et al. Clin Cancer Res. 2019 Nov 15;25(22):6564-6566. doi: 10.1158/1078-0432.CCR-19-2482. Epub 2019 Sep 12. Clin Cancer Res. 2019. PMID: 31515459

9

A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation.

Lala M, Li TR, de Alwis DP, Sinha V, Mayawala K, Yamamoto N, Siu LL, Chartash E, Aboshady H, Jain L. Lala M, et al. Among authors: mayawala k. Eur J Cancer. 2020 May;131:68-75. doi: 10.1016/j.ejca.2020.02.016. Epub 2020 Apr 15. Eur J Cancer. 2020. PMID: 32305010

10

Dose Finding in Oncology: What is Impeding Coming of Age?

Mayawala K, de Alwis D. Mayawala K, et al. Pharm Res. 2022 Aug;39(8):1817-1822. doi: 10.1007/s11095-022-03263-5. Epub 2022 Apr 26. Pharm Res. 2022. PMID: 35474158 Free PMC article.

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