Opportunities Bioanalytics Holds for Pharma

Bioanalysis is a progressive area for which the future holds exciting opportunities to improve sensitivity, accuracy, efficiency, data quality, assay throughput, data handling, analysis cost, and environmental impact.

FREMONT, CA: The advancement of the bioanalytical techniques brought a progressive discipline for which the future holds many opportunities to further innovation. The major impact of bioanalysis in the pharmaceutical industry is to get a quantitative measure of the drug and its metabolites. The purpose is to run the pharmacokinetics, toxicokinetics, bioequivalence, and exposure-response like pharmacokinetic studies.

Several bioanalytical techniques are performed in bioanalytical studies like hyphenated techniques, chromatographic techniques, and ligand binding assays. Here is more about the role of bioanalytical techniques and hyphenated instruments in evaluating the bioanalysis of the drugs.

Method of analysis is being continuously developed, enhanced, validated, collaboratively studied, and applied. Chromatographic separations are especially needed, which depend on the samples to be analyzed. The chromatographic procedure is essential for the systemic method to LC-MS/MS method development. In almost all cases, the desired separation can be attained easily with a few experiments. 

In other cases, considerable experimentation may be required.

Since many pharmaceutical compounds are polar, reverse phase chromatography is usually tried first in which non-polar stationery is utilized. The mobile phase includes water or buffer and an organic phase. Hence polar compounds get eluted first, and non-polar compounds are retained for a longer period. The stationary phases utilized in reverse phase chromatography are n-octadecyl, n-octyl, ethyl, phenyl, cyano, diol, and hydrophobic polymers. It is the first option for most samples, particularly neutral or un-ionized compounds that dissolve in water-organic compounds. The normal phase is tried if the reverse phase is not succeeded, where the sample may be strongly retained with complete acetonitrile as mobile phase.

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A bioanalytical method involves procedures involved in collecting, processing, storage, and analyzing a biological matrix for a chemical compound. Bioanalytical method validation (BMV) is used to establish that a quantitative analytical method is suitable for biochemical applications. It covers the quantitative measurement of Xenobiotics of drugs.