Cellular uptake and efflux of the tea flavonoid (-) epicatechin-3-gallate in the human intestinal cell line Caco-2

JB Vaidyanathan, T Walle - Journal of Pharmacology and Experimental …, 2003 - ASPET
(-)-Epicatechin gallate (ECG) is one of the flavonoids in green tea, which has been demonstrated
to have cancer-preventive properties in many model systems. However, the extent and …

Transport and metabolism of the tea flavonoid (–)-epicatechin by the human intestinal cell line Caco-2

JB Vaidyanathan, T Walle - Pharmaceutical research, 2001 - Springer
Purpose: Tea flavonoids, including (–)-epicatechin (EC), have been suggested to have
chemopreventive properties in cancer. However, there is limited knowledge of the oral …

Glucuronidation and sulfation of the tea flavonoid (−)-epicatechin by the human and rat enzymes

JB Vaidyanathan, T Walle - Drug metabolism and disposition, 2002 - ASPET
(−)-Epicatechin (EC) is one of the flavonoids present in green tea, suggested to have
chemopreventive properties in cancer. However, its bioavailability is not clearly understood. In the …

Comparing various in vitro prediction criteria to assess the potential of a new molecular entity to inhibit organic anion transporting polypeptide 1B1

J Vaidyanathan, K Yoshida, V Arya… - The Journal of Clinical …, 2016 - Wiley Online Library
Abstract Evaluation of organic anion transporting polypeptide (OATP) 1B1–mediated drug‐drug
interactions (DDIs) is an integral part of drug development and is recommended by …

Impact of the US FDA “Biopharmaceutics Classification System”(BCS) guidance on global drug development

…, DP Conner, P Seo, J Vaidyanathan… - Molecular …, 2017 - ACS Publications
The FDA guidance on application of the biopharmaceutics classification system (BCS) for
waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this …

Leveraging clinical pharmacology data to assess biosimilarity and interchangeability of insulin products

J Vaidyanathan, YMC Wang, D Tran… - Clinical Pharmacology …, 2023 - Wiley Online Library
There is over a hundred years of clinical experience with insulin for the treatment of diabetes.
The US Food and Drug Administration (FDA) approved the first insulin biosimilar …

Drug permeability-best practices for Biopharmaceutics Classification System (BCS)-based biowaivers: a workshop summary report

…, D Painter, YC Tsang, J Vaidyanathan… - Journal of …, 2023 - Elsevier
The workshop “Drug Permeability - Best Practices for Biopharmaceutics Classification
System (BCS) Based Biowaivers” was held virtually on December 6, 2021, organized by the …

Predicting food effects on oral extended-release drug products: a retrospective evaluation

P Zou, J Vaidyanathan, D Tran, K Raines… - The AAPS Journal, 2023 - Springer
Theoretically, the risk of food effects for extended-release (ER) products compared to IR
products may be less because: (1) postprandial physiological changes are usually transient and …

Kidney function changes with aging in adults: comparison between cross‐sectional and longitudinal data analyses in renal function assessment

…, A Hand, P Young, J Vaidyanathan… - … & Drug Disposition, 2015 - Wiley Online Library
The study evaluated whether the renal function decline rate per year with age in adults varies
based on two primary statistical analyses: cross‐section (CS), using one observation per …

Type 2 diabetes in pediatrics and adults: thoughts from a clinical pharmacology perspective

J Vaidyanathan, S Choe, CG Sahajwalla - Journal of pharmaceutical …, 2012 - Elsevier
Type 2 diabetes results when insulin secretion is unable to keep the plasma glucose levels
as per acceptable range. This leads to chronic hyperglycemia and its associated …