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Publications

In vitro evaluation suggests fenfluramine and norfenfluramine are unlikely to act as perpetrators of drug interactions

Parthena Martin, Maciej Czerwiński, Pallavi B. Limaye, Brian W. Ogilvie, Steven Smith, Brooks Boyd Abstract Studies support the safety and efficacy of fenfluramine (FFA) as...

In vitro evaluation of fenfluramine and norfenfluramine as victims of drug interactions

Parthena Martin, Maciej Czerwiński, Pallavi B. Limaye, Seema Muranjan, Brian W. Ogilvie, Steven Smith, Brooks Boyd Abstract Fenfluramine (FFA) has potent antiseizure activity in severe,...

A Guide to In Vitro CYP Inhibition Studies: Elements of Study Design and Important Considerations in Data Analysis

The USFDA, along with other regulatory agencies such as the EMA in Europe and PMDA in Japan, recommend evaluating investigational drugs for their potential to...

In Vitro Strategies for Evaluating Non-CYP Metabolism Pathways

While cytochrome P450 (CYP)-mediated metabolism continues to be of primary concern for the majority of new small molecule drug candidates, efforts to develop compounds that...

SAFETY FIRST: Assessing drugs early can preclude regulatory and health issues

Authors: Madison Esely-Kohlman, Dr. Maciej Czerwinski, Dr. Pallavi Limaye, Dr. Brian Ogilvie A Guide to When & Why to Evaluate ADME/PK & Drug-Drug Interactions With...

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 Pharmaceuticals 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...