The Five Essential Services Offered By Bioanalytical Labs

A Bioanalytical laboratory or bioanalytical CRO is an establishment that primarily organizes and operates several chemical, clinical, nonclinical, and physical tests to obtain scientific data. Hence, bioanalytical labs are crucial mediators of several drug discovery and development projects.

With the options of numerous bioanalytical laboratory services, it is difficult to select a specific bioanalytical lab for outsourcing studies. There are several factors, such as method development services and bioanalysis method validation, that sponsors must consider before choosing bioanalytical lab services. However, there are five essential services sponsors must focus on while choosing a bioanalytical laboratory. Reliable outsourcing partners such as NorthEast bioanalytical laboratories always ensure that these five essential services are offered by them. Let us dive deep into each of these services.

Drug metabolism and pharmacokinetics (DMPK)

DMPK studies are a crucial part of bioanalytical lab offerings. They focus on the safety and efficacy of potential drug candidates. Besides, DMPK evaluations form the basis of drug selection before they enter subsequent clinical trials. Absorption, distribution, metabolism, excretion, and toxicity are the core elements of DMPK analysis. A thoroughly optimized DMPK profile ensures that drug-drug interactions, bioavailability, and related risks are optimally evaluated. Besides, DMPK studies reduce drug attrition rates and eventually increase the total efficacy.

Toxicology studies

Toxicology studies are one of the most crucial factors that dictate the success of a drug development project. Hence, they are a must service that a reliable analytical laboratory will offer to its clients. Toxicology studies include several tests, such as dose range-finding studies, acute and repeated dose studies, maximum tolerated dose studies, and many more. However, laboratories offering this service must ensure that toxicological studies have GLP compliance. Ultimately, early toxicology studies help identify the initial safe drug doses for subsequent human studies.

Dose formulation analysis

Dose formulation studies help researchers identify the initial drug concentration and assess formulation stability and homogeneity. Although the regulatory guidance for formulation sample analysis is limited, bioanalytical labs must follow the US FDA bioanalytical guidance. Researchers test and verify several vehicles during early exploratory nonclinical studies. These analyses help them determine the ideal vehicle for delivering the novel drug compound.

Biomarker testing

Biomarkers are powerful tools to measure biological or pathological responses. Besides, they are the foundational parameters for assessing pharmacological interventions. Physicians rely on biomarkers to evaluate disease conditions. Hence, biomarker testing must be the number one service that laboratories must offer to their customers.

Today biomarker testing has become an integral part of drug development studies. Biomarker assays in the early preclinical stage help researchers determine the drug action and help them choose an ideal drug candidate. Furthermore, biomarker testing is increasingly beneficial in stratifying individual patients to personalized therapeutic interventions.

Bioavailability and bioequivalence studies

Bioavailability studies measure the drug concentration at the site of drug action or in the systemic circulation. On the other hand, bioequivalence studies are critical for generic drug products. Bioequivalence studies help sponsors demonstrate equivalence between a generic drug and a reference-listed drug product. Hence, bioavailability and bioequivalence is also necessary service that bioanalytical laboratories have for their customers.

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