Drug Development: The Role of Analytical and Bioanalytical Sciences

The Active Pharmaceutical Ingredient (API) is usually delivered in a vehicle; the drug is dissolved in a solution, diluted, or encased in a capsule for oral delivery, among other common administration techniques.

FREMONT, CA: Analytical and bioanalytical sciences play a critical part in supporting the drug development process in clinical and preclinical settings. From authenticating accurate dosage levels to the measurement of drug connection levels in biological matrices, analytical tools offer crucial data to ensure the drugs are effective and safe.

Bioanalysis has historically been employed to assess the existence of drugs in biological fluids for the purpose of forensic toxicology. The growth of pharmacokinetics in the 1930s pushed the interest in bioanalysis for estimating new drug candidates. Early assays were short of specificity that presented complications in distinguishing between a drug and its metabolites. Differentiation among the drugs and their metabolites gained traction when a few metabolites were found to be toxic or found to hold discrete therapeutic value.

The advancement of chromatographic methods to separate drugs from their metabolites started in the 1940s with paper chromatography trailed by Gas Chromatography (GC) in the 1950s. The late 1960s and early 1970s saw a change from GC toward High-Pressure Liquid Chromatography (HPLC). 

This new separation method combined with fluorescent and ultraviolet detectors’ development offered greater sensitivity to match the rising potency of drugs under development during the 1970s and 1980s.

The Function of Analytical and Bioanalytical Sciences in Drug Development

In clinical and preclinical environments, drugs are rarely managed in their pure form. The Active Pharmaceutical Ingredient (API) is usually delivered in a vehicle; the drug is dissolved in a solution, diluted, or encased in a capsule for oral delivery, among other common administration techniques. During the clinical and preclinical trials, the API’s concentration should be verified by dose formulation analysis to make sure that the right dosage is managed. Dose formulation analysis needs separation of the API from the vehicle and other impurities so that the correct data of the data can be calculated.

To measure the drug’s bioavailability and fate in the biological system, information is collected by analyzing samples of biological fluids drawn from dosed animals or humans. Accurate analysis of drug concentration in biological fluids needs the separation of drug from the biological fluid. At present, these types of analyses are most often performed employing liquid or gas chromatography in accordance with several detectors.

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