Drug metabolism and pharmacokinetics (DMPK) is imperative for the safety evaluation of a new drug. Suboptimal DMPK studies can be responsible for the failure of new drugs in the clinical trial phases.

The identification of applicable DMPK studies is necessary for the de-risking of candidate pharmaceutical molecules. DMPK studies can help in the optimization of compounds for the evaluation of drug-drug interactions, bioavailability, and related risks of the drug. The accurate assessment of DMPK profiles can minimize the attrition rate of the drug molecules and increase the efficacy of drug discovery.

What DMPK services do you need during drug development?

A DMPK study can shed light on the understanding of dosage, route of administration, toxicity level, PK/PD interactions, and other PK parameters. Standard DMPK studies at reputed laboratories utilize between two and four animal doses for testing a generic formulation.

DMPK studies are necessary throughout the phases of drug discovery, preclinical testing, and clinical trials. The standard DMPK study should include the following tests –

i. In-vitro ADME studies
ii. Ex-vivo ADME studies
iii. Additional DMPK studies

(DMPK pharmacokinetics in animal models during the pre-clinical phase, method development, validation and analysis of human samples in the clinical phase)

What is the importance of ADME during DMPK study?>

ADME refers to absorption, distribution, metabolism, and excretion of the new compound. Modern laboratories typically add studies of toxicity to the set of ADME tests. The optimization of the ADMET tests is of paramount importance for the early stages of drug discovery.

The results of any ADMET study determines how much drug is available in a biological system, how much of it will reach the target, and by what time the remnants will be excreted.
Results from in vitro ADME studies provide an insight into the physicochemical properties and the structure of the new chemical entity (NCE). The already reputed laboratories have their set of standardized protocols that help in the maximization of throughput and minimization of lead times. However, experienced teams can tailor client-specific solutions for particular drug molecules.

Why should you insist on ADMET studies during DMPK analysis?
The integration of ADMET during the early phases of testing can provide proof-of-concept for the efficacy of animal models. That can generate the necessary parameters for testing the compound in human models during the clinical trial phases, including clinical dose and exposure.

Why are DMPK studies imperative during all stages of drug development?

Therefore, DMPK screening is a part of the early phases of routine drug development. The solubility, metabolism, permeability, and drug-drug interactions influence the pharmacological efficiency of a drug in its developmental stages. Accurate selection and execution of DMPK/ADMET studies help in establishing the safety profiles of new drugs during development.

Every established and reliable bioanalytical laboratory has a dedicated team that conducts the ADME/DMPK studies. A dedicated, trained, and collaborative bioresearch team ensures that the DMPK studies suit the need of the client, comply with the FDA guidelines and their budgetary concerns.

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