Analytical lab testing is vital for the pharmaceutical industry to ensure drug products are safe and effective for the patient population. Analytical tests such as ADA immunogenicity testing are critical for analyzing drug components and their reactions with other substances. Analytical laboratory services have several testing methods to assess the safety and efficacy of new drug compounds.
These tests include functional assessments, chemical analysis, and health-related testing. All these test types can be performed using equipment or manually. For example, drug developers use LC-MS testing to study drug composition while employing physical assessments to evaluate the therapeutic potential of drug compounds. The current article focuses on analytical labs that can help unlock the efficacy and safety of drug compounds.
Analytical laboratory services for understanding drug efficacy and safety
Analytical lab testing procedures to assess the safety and efficacy of a drug product may range from informal individual methods to randomized clinical studies. However, not one technique is usually applicable to all drug products. A combination of different analytical tools is often used to study the efficacy and safety of products.
Various regulatory bodies have dedicated requirements and guidance for developing drug products. Notably, evaluating the safety and efficacy of drug products and medical devices differs from the terms and conditions for surgical and medical procedures. So, let us dive deep and understand the different types of analytical lab testing for deciphering and evaluating drug efficacy and safety.
Analytical lab testing involves several animal and biochemical evaluations during the preclinical stage of drug development. The primary aim in this stage of analytical lab testing involves gaining insights into appropriate testing parameters for human studies and establishing performance criteria to comply with regulatory requirements. Besides, the compounds are analyzed for quantity, purity, and quality of the active ingredients.
Analytical lab testing services often specialize in animal testing to determine the drug’s potential therapeutic activity and ability to induce unwanted toxicity. Determining the degree of toxic effects is a significantpart of animal preclinical studies. Analytical laboratories evaluate the degree of toxicity in terms of physiological and chemical analysis. On the other hand, therapeutic efficacy is based on the pharmacokinetic and bioavailability properties of the product.
Epidemiological and statistical evaluations are other crucial aspects of analytical lab testing to assist efficacy and safety studies. Epidemiological methods for evaluating safety and efficacy include prospective, retrospective, and controlled clinical trials.
Retrospective studies are comparative studies between two groups, one with a disease and the other without. These studies determine the difference in exposure to critical elements between the two study populations. On the other hand, prospective studies involve considering individual histories of subjects, both exposed and unexposed to specific factors under observation. A significant advantage of this type of study is the relative clarity for selecting study parameters and comparison groups.
Control clinical trials have a more rigid and structured approach. All study participants are assigned to an experimental or control group. Controlled clinical trials are particularly robust because the investigator has no control over treatment choice, removing any associated bias. However, irrespective of the approach used for assessing efficacy and safety, analytical lab testing has extensive experience handling different bioanalytical technologies.