Introduction:
The development of the bioanalytical techniques brought a progressive discipline for which the future holds many exciting opportunities to further improvement. The main impact of bioanalysis in the pharmaceutical industry is to obtain a quantitative measure of the drug and its metabolites. The purpose is to perform the pharmacokinetics, toxicokinetic, bioequivalence and exposure response like Various bioanalytical technique performed in bioanalytical studies such as hyphenated techniques, chromatographic techniques, and ligand binding assays. This review extensively highlights the role of bioanalytical techniques and hyphenated instruments in assessing the bioanalysis of the drugs.
As per Bioanalytical Method Validation (BMV) guidelines for industry, these guidelines are applied to bioanalytical methods that are used for the quantitative determination of drugs and their metabolites in biological matrices such as plasma, urine and preclinical studies. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method developed and used for quantitative measurement of analytes in a given biological matrix is reliable and reproducible.
Method Development:
Method of analysis are being routinely developed, improved, validated, collaboratively studied and applied. Chromatographic separations are mainly required which depend on the samples to be analyzed. The chromatographic procedure is important for the systemic approach to LC-MS/MS method development. In most cases as desired separation can be achieved easily with only a few experiments. In other cases, a considerable amount of experimentation may be needed.
Method Validation:
Method Validation can be used to judge the quality, reliability and consistency of analytical results it is an integral part of any good analytical practice.
Biolyte Solution
- Sequence Creation & Request
- Management of Biological samples
- Sequence Export Data Export from the machine
- All Data Collected from the Machine Can Be Print
- Suited for File Type like Waters, Sciex & Thermo
- Handle & Management of Multi-Phase Trials
- Biolyte -Inbox Data review
- QC/QA person can review all data easily
- Easy for Audit trial
- Compilation of BA Results