Drug discovery and development is a challenging initiative. It takes around 10 to 15 years and approximately $1 billion for a new drug to reach the market shelf. The drug discovery process focuses on identifying compounds potentially translating into drug compounds. On the other hand, drug development is the process of identifying novel chemical entities that have the potential to become a safe and efficacious drug product. Over the years, drug discovery and development have witnessed several innovative changes. Pharmacokinetics studies are one such promising contributor.
Today pharmacokinetic study has become a crucial component of drug discovery and development. Like ADA immunogenicity testing, bioanalytical services focus on bioanalysis and research services in PK/PD testing. Therefore, the current article discusses the crucial role of bioanalysis services provider such as NorthEast bioanalytical services for pharmacokinetic studies.
The crucial role of pharmacokinetic lab
Bioanalysis is crucial for drug discovery and drug development. Data from bioanalytical studies are critical for defining the features of a potential drug product. Besides, they are vital in helping researchers understand specific areas of treatment where a particular molecule can be the most effective. Moreover, bioanalysis data forms a crucial component of regulatory filings. Such unique requirements drive the need for finding partner laboratories with in-depth expertise in developing appropriate assays.
Bioanalytical studies are designed and developed to estimate biologics and drugs in preclinical and clinical samples accurately. Such estimates are critical for numerous aspects of drug development, such as bioavailability and bioequivalence evaluation, toxicokinetic analysis, clinical pharmacology data, and clinical pharmacokinetic studies. These studies support and supplement the decision-making process and other pharmacology studies for the safety, approval, and labeling of a drug product.
However, bioanalytical studies have scientific importance that goes beyond the needed regulatory requirements. Bioanalysis provides critical information related to drug safety. Bioanalytical studies help identify the maximum tolerated dose levels and pharmacokinetic features of a drug product. Researchers use this pharmacokinetic data to understand drug half-life, drug exposure, and other crucial parameters to determine drug doses that deliver adequate efficacy without undue adverse reactions.
Robust pharmacokinetic studies are necessary during drug research and development projects to help researchers make crucial decisions. These timely decisions around drug development, such as the first-in-human drug doses in clinical trials, are based on preclinical pharmacokinetic data or assessing the time course of a drug product after administration.
As part of a drug development team, bioanalytical services CROs offer expertise in developing the right strategy for a specific drug product and help sponsors overcome any difficulties during the R&D process. Besides, pharmacokinetic labs have professionals specializing in advanced PK testing tools such as LC-MS/MS and other ligand binding assays. They specialize in complex method development and validation protocols. Besides each bioanalytical service CRO brings leading-edge technology in assay development for assessing samples in different biological matrices.
In conclusion, pharmacokinetic studies form the backbone of a successful drug development project, and bioanalytical services CRO are vital in pharmacokinetic studies.