Safety & Pharmacovigilance

• Absorption (A): How the drug enters the bloodstream from the site of administration.
• Distribution (D): How the drug is spread throughout the body’s tissues and organs.
• Metabolism (M): How the body chemically transforms the drug (often via enzymes in the liver).
• Excretion (E): How the drug and its metabolites are removed from the body.

Understanding the pharmacokinetic drug profile is indispensable for:

• Dose Selection: Informing the selection of safe and effective starting doses for human clinical trials.
• Exposure Assessment: Linking drug exposure to observed efficacy and toxicity.
• Predicting Human PK: Using animal PK data to predict how the drug might behave in humans.
• Drug-Drug Interactions: Identifying potential interactions with other medications

Our preclinical support includes specialized exploratory DMPK (Drug Metabolism and Pharmacokinetics) studies, which provide invaluable early insights into these critical parameters, helping to identify promising candidates and deselect those with unfavorable profiles.