The CRO market is enormously competitive. In 2018, the CRO market cap reached $39 billion and was expected to cross the $51 billion mark by 2024. Large bioanalytical services CROs are increasingly acquiring and merging to increase their portfolio. On the other hand, small and midsize bioanalytical testing services focus on a personalized approach, budget-friendly solution, and contact flexibility.
The drug development process is a complex endeavor. To give an overview of the drug development process, researchers strive at identifying potential drug compounds to treat diseases and medical conditions. Hence, efficient and reliable resources are needed at every phase of drug development. Here is where partners such as NorthEast bioanalytical laboratories help sponsors bridge the gap between drug discovery and product launch. Data research, preclinical and clinical studies, project management, and post-approval changes are some activities bioanalytical laboratory services CRO conduct for sponsors and clients. The current article highlights five essential bioanalytical services CROs provide for drug discovery and development projects.
Pharmacokinetic studies are necessary to assess drug exposure over time. Pharmacokinetic parameters are judged based on how a drug is absorbed, distributed, metabolized, and excreted from the body. Let us understand each of these parameters in brief.
- Absorption is the process through which a drug enters the body.
- Distribution focuses on a reversible transfer of a drug product from one part to another
- The metabolism process converts a drug product into its metabolites
- Finally, excretion removes the drug and other substances from the body.
Bioanalytical laboratories perform toxicology studies to evaluate drug safety by determining adverse effects on organs and tissues. Initial nonclinical toxicology studies are performed in animal species before advancing to clinical trials. These initial toxicology studies are crucial to determining therapeutic doses in first-in-human studies. Toxicology studies have several designs, including dose range-finding studies, single and acute dose toxicity studies, repeated dose toxicity studies, and maximum tolerated dose studies.
Bioequivalence and bioavailability studies
Bioequivalence and bioavailability studies are necessary to measure and compare systemic drug circulation. The bioavailability of a drug product is the amount of drug available at the site of action. Most drugs are consumed orally. Therefore, they get into systemic circulation through the GI tract. These drugs then reach the site of action through the systemic circulation.
On the other hand, bioequivalence studies are foundational components of generic drug products. Two drugs are bioequivalent when they have similar bioavailability.
Immunogenicity testing measures the immune response triggered due to a drug product. This immune response can affect the safety and efficacy of a drug product. Hence, immunogenicity testing is a significant step in the drug development process. However, these assays are inherently complicated as they involve assessing interactions between the drug, target, and biological matrices. Hence, bioanalytical services help sponsors choose an ideal assay format for optimal assay development and validation.
Biomarker testing is a crucial tool for assessing biological indicators in normal and diseased conditions, plus evaluating drug responses. Besides, biomarker analysis
are vital at all phases of drug development. They are critical, particularly in the early stages of drug discovery, where scientists have to make the go/no-go decisions. Therefore, bioanalytical services help conduct early biomarker testing to decide the fate of a drug candidate.