Drug Metabolism & Pharmacokinetics
Upon administration, a drug’s effect is determined by how well it is Absorbed, Distributed, Metabolized in and Eliminated from the body. The Drug Metabolism & Pharmacokinetics (DMPK) team characterize these ADME properties and determine how to optimize the drug exposure for optimal performance along with other disciplines (pre-clinical and clinical). These efforts aid in selecting the safest and best candidate along with the optimal dosage regimen for the first-in-human, Proof of Concept and pivotal clinical studies. The DMPK team also looks at how the drug should be formulated in collaboration with formulation development scientists (e.g. tablet, capsule, or an oral or injectable solution), and evaluates potential interactions with food or other drugs, to guide dosing to reduce side effects or maintain therapeutic effectiveness.
The information gathered by the team can come from three sources:
- Preclinical experiments conducted in vitro or in vivo to study the integrated pharmacology of the molecule
- Iterative modeling activities translating preclinical data into clinical development strategy, and
- Clinical data collected from healthy volunteers and patients to evaluate human safety and efficacy
All data are used in an iterative manner, where the pre-clinical data is used to better design the clinical studies and the clinical data are continually used to improve the preclinical models. The information collected in clinical pharmacokinetics studies is used by the health authorities to write prescribing information to help the patients and physicians in the optimal use of the product.
This illustrates NIBR’s goal of bringing medicines to the patient as quickly as possible with minimal time and effort spent in preclinical studies.