Drug Metabolism

Drug metabolism and pharmacokinetics (DMPK) is a core discipline in drug development that considers the biotransformation of a drug compound...

Highlights from the recent webinar presented by our newest expert consultant, Dr. Pallavi Limaye In her recent webinar (now available for...

The main aim of drug development is to get a compound that has a therapeutic effect into the form of...

1. Collect high-quality data to make informed, confident go/no go decisions for moving your drug candidate forward If you need...

Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...

Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...

Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...

Generally, a drug’s effects on enzyme and transporter activity are examined independently in a drug development program, but what if...

Why do induction studies? Induction potential is an important piece of the drug-drug interaction (DDI) component of an IND submission. Simply put, we...