Bioanalytical laboratories are involved in numerous pharmaceutical studies. These studies include toxicokinetics, pharmacokinetics, bioequivalence, and bioavailability assessments. However, bioavailability and bioequivalence are different. The difference between bioequivalence and bioavailability studies is that bioavailability is the extent of the drug compound available at the site of action, whereas bioequivalence compares the bioavailability profile of two drug products.
Due to increasing demands in clinical and nonclinical drug development, drug developers now outsource studies to different bioanalytical labs. Bioanalytics companies offer tactical and strategic resources depending on financial, business, and technical factors. Hence, choosing the right bioanalytical laboratory becomes crucial for saving time and resources. The current article shares factors to consider for successful collaboration with a bioanalytical laboratory.
How to choose the right bioanalytical laboratory?
Outsourcing studies to bioanalytical labs can help manage the flow of projects entering product development. This approach can help acquire the strengths of bioanalytical laboratories and provide additional operational and scientific support to make critical decisions. Depending on experimental requirements, bioanalytical laboratories can deliver scientifically robust methods that can help initiate projects and acquire vital drug development data. So, let us understand the factors that companies must consider when choosing a bioanalytical laboratory.
Companies must first identify whether the collaboration will be a strategic or tactical commitment. A strategic partnership includes bioanalytical laboratories offering value-added benefits on a long-term basis. This association involves leveraging sponsors’ resources to maximize the development of new biological or pharmaceutical products.
On the other hand, a tactical strategy primarily focuses on completing short-term work that may have arisen due to inadequate ability or human resources. Hence, this method is more delivery-focused. Drug developers employ a tactical technique to streamline workflow and gain additional capacity to fulfill exceeding demands. Hence, identifying the preliminary approach is ideal before choosing the right bioanalytical laboratory.
Companies should make numerous qualitative and quantitative assessments while choosing a bioanalytical laboratory. These assessments should evaluate the capacity, capabilities, and scientific expertise of a bioanalytical laboratory.
Sponsors should identify the potential of a bioanalytical laboratory to support method development and validation with production capacities to achieve the desired drug development goal. This goal requires a definite number of analytical resources in each area of expertise. Identifying the capacity to address and acquire resources and deliver results is a critical deciding factor.
An ideal bioanalytical laboratory should have deep expertise and talent for executing the desired project on time. Hence, identifying a laboratory’s experience in quality systems, information technology, and regulatory submissions is vital for improving the efficiency and quality of study research. A bioanalytical lab focused on banking on the strength and experience to deliver desired results is an ideal outsourcing partner.
Finally, quality is of utmost importance in pharmaceutical drug development. Besides, the US FDA requires GLP compliance for numerous nonclinical studies. Hence, identifying bioanalytical laboratories with adequate quality control systems is critical for complying with regulatory requirements.
In Conclusion
Sponsors should identify internal goals and match them with the expertise of a bioanalytical laboratory while choosing the right laboratory partner.