Bioanalysis Labs
Bioanalytical studies or bioanalysis is the quantification of drugs and their metabolites in biological study samples, such as blood, plasma, and serum, to determine their efficacy and safety. With an increasing demand for novel pharmaceutical drug products, drug developers and pharmaceutical companies often rely on partner bioanalytical labs. These bioanalytical laboratories support drug developers by conducting routine bioanalytical experiments or fulfilling specific research requirements.
Bioanalytical services providers quantify and evaluate biological molecules at different concentrations. They also support complementary evaluations such as forensic drug testing, anti-doping tests in sports, and biomonitoring and environmental assessments. The current article discusses the significance of different bioanalytical labs, such as pharmacokinetic CROs, in drug development.
Importance of bioanalytical lab services
An analytical method is a set of criteria used to collect, process, store, and analyze molecules in biological matrices. Analytical laboratories help determine the suitability of a bioanalytical method for biochemical and biomedical applications through robust method validation. They develop bioanalytical assays and validate them for accurate analyte quantification in different biological samples to evaluate drug efficacy and safety.
Experimental data is only reliable and reproducible if it is acquired by qualified individuals using methodologies and platforms with rigorous validation. Bioanalysis labs have highly qualified scientists and validated techniques to deliver reliable, reproducible, and accurate experimental data. Their instruments undergo validation in terms of accuracy, specificity, sensitivity, efficiency, reproducibility, and stability studies. They offer robust quantitative estimations of drugs and their metabolites for several pharmaceutical evaluations, including bioequivalence, pharmacokinetic/pharmacodynamic studies, toxicokinetic evaluations, and bioavailability and bioequivalence assessments.
The characteristics of bioanalytical studies during drug development depend on specific requirements and tasks at each stage of drug discovery and development and the study material required for bioanalysis. Bioanalytical laboratories are critical for discovering and developing pharmaceutical drug products. Besides, the methodology developed by these laboratories helps quantify analytes in complex biological samples, including blood, plasma, serum, urine, and cerebrospinal fluid.
Must Read: CONSIDERATIONS FOR SELECTING A MASS SPECTROMETRY SERVICE COMPANY
Today, the rapid development of innovative therapeutics is due to a growing knowledge and understanding of disease biology, which has been possible due to advances in bioanalytical development. Analytical laboratories have played a massive role in advancing bioanalytical research. Today advances in methodology and bioanalytical methods have helped researchers perform experiments and acquire results that were unattainable in the past, such as data on neurotransmitter release and neuron activity. The accurate estimation of endogenous substances and drugs in biological matrices is crucial for scientific evaluations. Bioanalytical laboratories employ different strategies to design efficient and robust bioanalytical methods to study biomolecules and their physical properties.
The necessity of robust and reliable bioanalytical methods during drug discovery and preclinical and clinical studies is widely accepted in the scientific community. Hence, sample preparation and method validation must be timely conducted to demonstrate accuracy and reliability in analytical results. It is necessary to obtain extract with greater extraction efficiency.
In Conclusion
Bioanalytical laboratories have in-depth expertise in developing and validating bioanalytical methods for every stage of drug development and sample preparation techniques.
