Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation

…, S Friedrich, MA Heathman, DP de Alwis, V Sinha - The AAPS journal, 2005 - Springer
Pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) are well-recognized
powerful tools that enable effective implementation of the learn-and-confirm …

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

M Lala, TR Li, DP de Alwis, V Sinha… - European Journal of …, 2020 - Elsevier
Background Pembrolizumab is approved for multiple cancer types at 200 mg and 2 mg/kg
dose every 3 weeks (Q3W). We used a model-based approach to compare the exposure of …

Pembrolizumab exposure–response assessments challenged by association of cancer cachexia and catabolic clearance

…, K Mayawala, J Kang, SW Ebbinghaus, V Sinha… - Clinical Cancer …, 2018 - AACR
Purpose: To investigate the relationship of pembrolizumab pharmacokinetics (PK) and
overall survival (OS) in patients with advanced melanoma and non–small cell lung cancer (…

In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america …

…, G Kumar, D Moore, S Ripp, J Silva, V Sinha… - Drug Metabolism and …, 2009 - ASPET
Cytochrome P450 (P450) induction is one of the factors that can affect the pharmacokinetics
of a drug molecule upon multiple dosing, and it can result in pharmacokinetic drug-drug …

Predicting the effect of cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling submissions to the US Food and …

…, JA Grillo, L Zhang, KS Reynolds, V Sinha… - Clinical …, 2015 - Springer
Background and Objective The US Food and Drug Administration (FDA) has seen a recent
increase in the application of physiologically based pharmacokinetic (PBPK) modeling …

A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin–treated patients with type 2 …

…, RF Arakaki, MJ Prince, Y Qu, VP Sinha… - Diabetes …, 2012 - Am Diabetes Assoc
OBJECTIVE To evaluate whether LY2605541 results in lower fasting blood glucose (FBG)
versus insulin glargine (GL). RESEARCH DESIGN AND METHODS This 12-week, …

[PDF][PDF] Phase I dose escalation and pharmacokinetic study of enzastaurin, an oral protein kinase C beta inhibitor, in patients with advanced cancer

…, J Riddle, J Schmidt, N Enas, V Sinha… - Journal of Clinical …, 2006 - Citeseer
Purpose This phase I study was conducted to determine the recommended dose of enzastaurin,
an oral protein kinase C beta (PKC) inhibitor, for phase II trials. Secondary objectives …

Model-based drug development: the road to quantitative pharmacology

L Zhang, V Sinha, ST Forgue, S Callies, L Ni… - … of pharmacokinetics and …, 2006 - Springer
High development costs and low success rates in bringing new medicines to the market
demand more efficient and effective approaches. Identified by the FDA as a valuable prognostic …

Predicting the effect of CYP3A inducers on the pharmacokinetics of substrate drugs using physiologically based pharmacokinetic (PBPK) modeling: an analysis of …

C Wagner, Y Pan, V Hsu, V Sinha, P Zhao - Clinical pharmacokinetics, 2016 - Springer
Background and Objective We recently published analyses regarding the predictive performance
of physiologically based pharmacokinetic (PBPK) models, submitted to the US Food …

Regulating digital ecosystems: bridging the gap between competition policy and data protection

B Kira, V Sinha, S Srinivasan - Industrial and Corporate Change, 2021 - academic.oup.com
Data collection and processing are at the core of rapidly growing business models, underpinning
the activities of technology companies and acting as a source of market power. The key …