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  Published Paper Details:

  Paper Title

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW

  Authors

  Dnyaneshwari B. Sapkal,  Gopal M. Shinde,  Manoj S. Charde,  Rita D. Chakole,  Rushikesh M. Doijad

  Keywords

Bioanalytical Method, Validation, Method Development, etc.

  Abstract


In this study, medicines and their metabolites are often quantified in plasma matrices using bioanalytical techniques. These techniques should be applied to investigations in both nonhuman and human clinical research fields. A critical component of calculation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic research is the employment of the bioanalytical method for the quantitative assessment of medicines and their metabolites in biological medium. Method creation, method validation, and sample analysis are the three main responsibilities of bioanalysis. It is important to consider how environment, matrix, and procedural factors may affect the estimation of analyte in the matrix at each stage of the procedure, from setup to analysis. Each instrument has unique benefits and drawbacks. For the bioanalysis of small/large compounds, gas chromatography and HPLC have primarily been utilized, along with LC/MS/MS. In this review paper, it is advised that we add a few information on the development and validation of bioanalytical methods. We will be able to identify the medicine, its concentration, and its metabolite using these specifics, which will aid in quality control.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT2306259

  Paper ID - 239317

  Page Number(s) - c378-c387

  Pubished in - Volume 11 | Issue 6 | June 2023

  DOI (Digital Object Identifier) -   

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Dnyaneshwari B. Sapkal,  Gopal M. Shinde,  Manoj S. Charde,  Rita D. Chakole,  Rushikesh M. Doijad,   "BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION: A REVIEW", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.11, Issue 6, pp.c378-c387, June 2023, Available at :http://www.ijcrt.org/papers/IJCRT2306259.pdf

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ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
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