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Publications

An FGF15/19-TFEB regulatory loop controls hepatic cholesterol and bile acid homeostasis

Bile acid synthesis plays a key role in regulating whole body cholesterol homeostasis. Transcriptional factor EB (TFEB) is a nutrient and stress-sensing transcriptional factor that...

Effects of monocyte chemoattractant protein-1, macrophage inflammatory protein-1α, and interferon-α2a on P450 enzymes in human hepatocytes in vitro

Maciej Czerwiński, Krystal Gilligan, Kevin Westland, Brian W. Ogilvie Some immunomodulatory agents stimulate the release of cytokines capable of suppressing P450 enzymes and potentially affecting pharmacokinetics of coadministered medications. Cytokines...

2019 PMDA Guideline (English Translation), “Guideline on drug interaction for drug development and appropriate provision of information”

In 2019, the Phamraceuticals and Medical Devices Agency (PMDA) in Japan released the official English translation of their guidance for industry. Drug developers may also...

2017 FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies

Dr. Brian Ogilvie, Andrea Wolff While the 2017 FDA DDI guidance contains many important changes, the earlier timing of drug-drug interaction studies is perhaps the most...

Chapter 6: Biotransformation of Xenobiotics

Andrew Parkinson, Brian W. Ogilvie, David B. Buckley, Faraz Kazmi and Oliver Parkinson This book chapter will be part of Casarett and Doull’s Toxicology: The...

Strategies to improve the predictions accuracy of hepatic intrinsic clearance of three antidiabetic drugs: application of the extended clearance concept and consideration of the effect of albumin on CYP2C metabolism and OAT1B1-mediated hepatic uptake

Ryo Fujino, Kenta Hashizume, Shinsuke Aoyama, Kazuya Maeda, Kiyomi Ito, Kota Toshimoto, Wooin Lee, Shin-ichi Ninomiya, Yuichi Sugiyama The antidiabetic drugs glibenclamide, repaglinide, and nateglinide...

Challenges and solutions in today’s in vitro transporter research

Dr. Joanna Barbara In vitro drug transport assays are performed throughout drug development and range from simple permeability screens to kinetic assessments in complex assay formats. Sometimes interpreting...

Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies

Jane R Kenny, Diane Ramsden, David B Buckley, Shannon Dallas, Conrad Fung, Michael Mohutsky, Heidi J Einolf, Liangfu Chen, Joshua G Dekeyser, Maria Fitzgerald, Theunis...

An assessment of the in vitro inhibition of cytochrome P450 enzymes (CYP), UDP-glucuronsyltransferases (UGT) and transporters by phosphodiester- or phosphorothioate-linked oligonucleotides

Faraz Kazmi, Phyllis Yerino, Chase McCoy, Andrew Parkinson, David B Buckley and Brian W Ogilvie Oligonucleotides represent an expanding class of pharmacotherapeutics in development for...

Direct and cytokine‐mediated effects of albumin‐fused growth hormone, TV‐1106, on CYP enzyme expression in human hepatocytes in vitro

Maciej Czerwiński, Immaculate Amunom, Victor Piryatinsky, Hussein Hallak, Yousif Sahly, Oren Bar‐Ilan, Paul Bolliger, Merav Bassan Some biologics can modulate cytokines that may lead to...