Critical Role of DMPK Assay in the Drug Development Process

Author : nikkicross
Publish Date : 2020-06-08


Critical Role of DMPK Assay in the Drug Development Process

Over the last two decades, Drug Metabolism and Pharmacokinetics (DMPK) has established itself as an important part of drug development. DMPK data is used for the selection of drugs in the development process. It continues to be useful in overall drug development. DMPK profile of a drug provides valuable information like bioavailability, clearance, half-life, metabolic profile, etc.

DMPK Studies and Assays

About 20 years ago, sub-optimal DMPK profiles were identified as an important factor in the failure of potential new therapies. Since then, DMPK studies have grown immensely and now affect all stages of drug development. The intended effect is the reduction of attrition. More efficient use of DMPK assay in the early stages of drug development can substantially improve the profile of drugs that reach clinical trials.

An interesting result of this interest and focus has been the development of a wide range and variety of DMPK assays. The range of assays available makes it possible for researchers to conduct thorough studies. These can eventually result in more useful therapies and efficient drugs. On the downside, the variety of assays can also encourage inefficient screening cascades.

The efficient use of cascades during the Design Make Test Analyze (DMTA) cycle offers advantages in lead optimization and drug discovery. The use of screening cascades in the multi-disciplinary exercise helps determine the potency of the drug towards the target and its physiochemical properties. Data generated through in vitro methods is also utilized.

The efficiency of a compound or the need for optimization becomes sufficiently clear with DMPK screening assays. Further in vitro and in vivo studies can be conducted based on the results obtained through these assays. DMPK studies have been very useful using in silico models as well. It is expected that greater improvements and more integration of in silico processes will further help reduce attrition and time consumption.

Employing DMPK in the earlier stages also sees increased throughput capabilities for in vitro assays and pharmacokinetic parameters. DMPK assays have been fruitfully employed for predictive in vitro assays. This development alone has been immensely useful in various aspects, including the reduction of DDI (drug-drug interaction) risks.

DMPK Role in Optimization of a Drug

Optimizing a lead compound into a drug or therapy is a complex process. It’s also dependent on pressures related to perception, budgets, regulation, and society. In some ways, DMPK helps in reducing these pressures by enabling the development of more efficient drugs with lower attrition and costs. The use of DMPK studies related to in vitro, in vivo, and computational data also helps in translating the data to observed properties.

This translation plays a big role in shaping and monitoring the pharmacokinetic (PK) and toxicokinetic (TK) properties of a drug. These investigations are an important part of drug development and in understanding its absorption, distribution, metabolism, and excretion ADME assays properties.

During non-clinical development, PK and TK studies are, by definition, conducted on animals. The results and data so gathered using DMPK assay profiles and PK and TK studies are then managed for use in humans. Properties observed in animals may not necessarily be seen in humans, which is why these studies are useful in creating a safe dose and pattern suited for clinical use.



Category :health
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