The Next Horizons in Predicting Drug-drug Interactions

Physiologically-based pharmacokinetic (PBPK) modeling has arrived in prime time. This quantitative mechanistic framework, combining physiology with drug information and clinical trial design, has become an integral part of drug discovery and development. PBPK has also gained currency within industry and regulatory agencies. Its applications are numerous, including simulation of pre-clinical, healthy volunteer and special population … Continued

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s … Continued

Modeling the Influence of Ethnicity on Drug Disposition

Ever noticed how people from different ethnic backgrounds respond differently to drugs? For example, you may enjoy having a few drinks with friends on the weekend. When your friends with Eastern Asian heritage drink alcohol, it’s not uncommon for their faces to turn red. This happens because many East Asians possess an enzyme deficiency for … Continued

Assessing the Impact of Liver or Kidney Disease on Pharmacokinetics

Impaired hepatic or renal function can have a major impact on pharmacokinetics. There is a high risk of adverse events in patients with these conditions. Major pharmaceutical companies and drug regulatory agencies use physiologically-based pharmacokinetic (PBPK) modeling in virtual populations to investigate the impact of hepatic or renal impairment on drug exposure as a supplement to … Continued

Analyzing Complex In Vitro Experiments: It’s Not as Hard as You Think

Analyzing in vitro experiments can be challenging and time consuming. Yet, crucial decisions depend on accurate data analysis and interpretation early in development. Unfortunately, most lab-based scientists lack access to state-of-the-art models for analyzing in vitro data. A new tool enables the analysis of data generated from complexin vitro studies. These studies include assays using … Continued

How to Optimize Your Drug Label Using Modeling and Simulation Technology

As a trained pharmacist and scientist, I think a lot about patient care and how the drug development process impacts drug labels and the clinical use of medicines. Modeling and simulation technology encompasses methods such as physiologically based pharmacokinetic (PBPK) models. PBPK provides insight into drug mechanisms. It also helps clinicians provide the safest and … Continued

How to Revamp Your Approach to Conventional IVIVC Models

An IVIVC (in vitro-in vivo correlation) is a predictive mathematical model describing the relationship between the in vitro properties of a dosage form and the in vivo responses. Drug developers frequently find IVIVCs useful for a number of reasons: They can use dissolution tests as a surrogate for human bioequivalence (BE) studies. They can support … Continued

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