The Art and Science of Analytical Lab Testing for Drug Development
Analytical lab testing is vital for the pharmaceutical industry. Analytical laboratory services ensure that drug products are safe and effective for the intended patient population. Analytical labs are involved in assessing components and their reactions with other substances. Moreover, analytical lab testing includes bioanalytical methods ranging from LC-MS systems to immunoassays.Â
In drug development and the pharmaceutical industry, several tests play a unique role in ensuring the safety and efficacy of a drug product. These tests include health-related evaluation, functional assessments, toxicologist studies, and chemical analysis. Each test types has its applications, and its use depends on the intended question of interest. Therefore, the current article explores the art and science of analytical lab testing during drug discovery and development.Â
Analytical laboratory services for the pharmaceutical industry
Analytical tests incorporate all procedures that assess the study samples. These tests also include equipment for analytical testing. Some of these experiments are manual, while others are automated machines. For example, complete blood count tests, liver function tests, drug screening and chemical tests, and tests for glucose and cholesterol levels are preliminary analytical tests. On the other hand, there are more advanced analytical tests requiring manual tools or expensive chemicals. Some are administered in local clinical labs, while others require more sophisticated units.Â
Sample preparation forms a fundamental part of bioanalytical tests involving sample collection. Biological samples are particularly complex and require a preparatory step before analysis. Besides, each biological sample may require different treatments. For example, determining glucose levels through blood requires a specific treatment, while urine analysis does not. Moreover, the type of sample collected dictates the sample pretreatment steps. Routine analysis, such as determining sodium levels, requires no additional manipulation. On the other hand, more sophisticated techniques, such as LC-MS analysis, require sample treatment, such as solid-phase attraction or liquid-liquid extraction.Â
Analytical labs employ several quality control tests to determine the working capacity of a product. These tests include assessing the pH or acidity of a liquid or determining the active ingredients of a drug. Besides, additional analytical tests are required to verify harmful chemicals. Drug products may contain preservatives that could potentially interfere with biological processes. Therefore, developers often connect with analytical laboratories to assess contaminants or drug metabolites affecting efficacy and safety profiles.Â
Once a bioanalytical method is developed and optimized, analytical labs validate the method before routine use. Method validation is crucial to demonstrate the reliability of bioanalytical methods. Analytical labs begin with method validation by initiating a working theory. Once a theory is established, researchers gather data and analyze results based on predefined criteria. Moreover, some method validation parameters include sensitivity, specificity, accuracy, precision, the limit of detection, robustness, and stability.Â
Most Importantly
Analytical laboratory services are crucial during the clinical trial phase. Usually, small-scale and medium-sized pharmaceutical companies don’t have the resources and expertise to conduct studies. Therefore, they heavily rely on analytical laboratory services to conduct clinical trials on their behalf. Analytical laboratories are exposed to a wide range of clinical projects. They employ this expertise and help drug developers enroll, investigate and observe a pharmaceutical drug during human clinical trials. Besides, analytical labs are routinely exposed to regulatory checks and assessments. Hence, they always comply with up-to-date regulatory guidelines and requirements.Â
