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How Can Bioanalysis Accelerate Drug Development

The drug discovery and development is a crucial project that can take up to 10 years for market release and approximately USD 1 billion for completion. Bioanalysis plays a major role during these processes of drug discovery and development.

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How Can Bioanalysis Accelerate Drug Development

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  1. How Can Bioanalysis Accelerate Drug Development

  2. The drug discovery and development is a crucial project that can take up to 10 years for market release and approximately USD 1 billion for completion. The process involves generating various drug candidates and assessing all the underlying properties of these compound so that one NCE (Novel Chemical Entity) can be developed. The NCE is considered safe for administration by the humans for the treatment of intended disease or illness. Bioanalysis plays a major role during these processes of drug discovery and development. Understanding Bioanalysis Bioanalysis is a process of measuring the presence of metabolites in the given biological fluid such as plasma, blood, serum, urine, etc. A bioanalytical lab conducts two major activities during the study of bioanalysis. These activities include sample preparation and compound detection.

  3. The sample prepared for bioanalytics is achieved to test the presence of the bioanalytical drug in the bioanalytical fluids of the human body. The proteins are removed from the sample through processes such as solid phase extraction, liquid-liquid extraction, and protein precipitation.For compound detection, various methods are utilized by a bioanalytical lab such as high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), atmospheric pressure chemical ionization (APCI), ultra-high-pressure liquid chromatography (UPLC), etc. Validation Parameters For quantitative procedures included in bioanalysis, assessment of the validation parameters is imperative to prove the selectivity, accuracy, specificity, and precision of the method.

  4. Selectivity: The selectivity indicates the ability of the method to develop a response related to the target analyte such that this response is distinct from other responses. Accuracy: Accuracy is an indicator of the closeness of the outcome as obtained by the bioanalytical method in comparison to the actual value or concentration of the method. Precision: The precision of the method is obtained by using the method for different aliquots and the homogeneous volume of the sample that produces close results.

  5. Robustness: It is the measure of the ability of the sample to remain unchanged under the influence of small changes in the parameters. Stability: The stability checks the degradation ability of the sample analytes during the processing, preparing, and storing of the sample. Understanding all the validation parameters of bioanalysis corresponding to a pharmaceutical sample allows the acceleration of drug development. These parameters helpscientists to avoid unnecessary errors in the procedures in the later stages of drug discovery and development.

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