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Clearing Up Clearance in PK: What You Need to Know

Presented by Malcolm Rowland, Ph.D.
Tuesday, September 1 at 11:00 am ET US

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Abstract:

Recently, there have been new discussions about the definition and limitations of frequently used common pharmacokinetic parameters such as clearance, volume of distribution and bioavailability. For clearance, the concept of a 'well-stirred model' has been applied for years to estimate hepatic drug concentrations and translate laboratory observations such as in-vitro drug interaction studies into estimated in-vivo changes in drug clearance. Various alternative models to describe hepatic exposure have been proposed and compared.

About the Speaker:

  Malcolm Rowland is Professor Emeritus and former Dean, School of Pharmacy and Pharmaceutical Sciences, and member and former director (1996-2000), Centre for Applied Pharmacokinetic Research, University of Manchester, U.K. He is also Adjunct Professor, Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California San Francisco (UCSF) and Founder Member, NDA Partners. He was President, EUFEPS (European Federation for Pharmaceutical Sciences,1996-2000); VP FIP (International Pharmaceutical Federation, 2001-2009); Board Member, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs, 2004-2008); and Member, Governing Board, EU Network of Excellence in Biosimulation (Biosim, 2004-2009), He received his degree in Pharmacy and PhD, University of London, and was on faculty, School of Pharmacy, UCSF (1967-75) before taking up a professorship at Manchester (1975-2004). He has consulted widely in industrial pharmaceutical research and currently serves as chair, Simcyp SAB, a Certara company.

His main research interest is physiologically based pharmacokinetics and its application to drug discovery, development and use. He is also strongly associated with clearance concepts in pharmacokinetics. Author of over 300 scientific articles, and co-author, with Dr. TN Tozer, of the textbooks: Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications, and Essentials of Pharmacokinetics and Pharmacodynamics. He served as an editor of Journal of Pharmacokinetics and Pharmacodynamics (1973-2007), and since 1977 has organised regular residential workshops in pharmacokinetics.

He has been awarded honorary doctorate degrees from the Universities of Athens (Greece), Poitiers (France), and Uppsala (Sweden), and Honorary Membership, Royal College of Physicians (London). He received the 2012 Sheiner-Beal Award in Pharmacometrics, American Society of Clinical Pharmacology and Therapeutics; the 2011 Host Madsen Award, FIP; 2007 ACCP Distinguished Investigator Award; the Millennial Pharmaceutical Scientist Award (FIP BPS, 2000), and the 1994 AAPS Research Achievement Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism. He has been awarded fellowship of the (British) Academy of Medical Sciences, (British) Academy of Pharmaceutical Sciences, American College of Clinical Pharmacology (Hon), the Royal Pharmaceutical Society of Great Britain, British Pharmacological Society, AAPS, and the Institute of Mathematics. He has spent several short sabbaticals at the Office of Clinical Pharmacology, FDA.