DMPK or Drug Metabolism and Pharmacokinetics is a scientific discipline evaluating the safety and efficacy of a drug compound or candidate during the drug discovery, research and development process.
Over the years, DMPK has become one of the core disciplines for the pharma industry, and both small and big contract research organizations follow strict protocols and procedures to create, evaluate, research, discover, develop and market drugs tested for DMPK properties to the national and international markets.
Role of DMPK in Drug Discovery and Development
In its earlier avatar, the major contributors to the failure of a drug during the earliest stages of preclinical trials were the DMPK properties.
The next logical step for experts was to introduce tests related to DMPK studies in drug discovery, much before the drug was designed, created and readied for preclinical trials.
The realignment allowed DMPK to help scientists identify the right compound and candidate to reach the trials – resulting in a higher success rate for therapies and drugs tested and easing the way to clinical trials.
Tests during the early stages of drug discovery tests required to increase success rate are the potency of a drug candidate against a target protein, identifying the safety profile, balancing the optimized pharmacokinetics parameters and minimized drug-drug interaction (DDI).
ADME (absorption, distribution, metabolism, and excretion) properties are another critical aspect while identifying and evaluating DMPK properties. The DMPK role here is to enhance the design of the drug under evaluation as well as reduce or eliminate DDIs.
Another focus of DMPK is to reduce attrition. During drug research and development, it is the DMPK which are necessary to test the efficacy and safety profiles to ensure sufficient bioavailability and reduced DDI liabilities. The essentiality of this cannot be stressed enough, especially when comparing the microscopic attention by society, regulatory bodies, commercial houses and budget approvers.
One of the main objectives of the DMPK studies is to establish a dose and exposure effect, of the drug compound with the proteins and other metabolites in the human body.
Scientists evaluate and offer an assessment of the relationship as seen during various trials. It hence requires the efforts of a multi-disciplinary team. The team uses the DMPK parameters to optimize the benefit-risk ratio and expedite the successful completion of a trial.
Once the drug candidate and compound is identified, DMPK role becomes essential as its parameters are used to evaluate both ADME and PK properties.
The tests are carried out in relevant animal species during preclinical trials followed by clinical trials with human volunteers. Technological advancements have allowed scientists to improve analysis, identify reactive metabolites (potential) and interpret hepatotoxicity.
A good contract research organization takes the necessary steps to ensure the
DMPK studies are conducted as per the FDA guidelines to make sure the process is quick and efficiently.