AN OVERVIEW OF ANALYTICAL METHOD VALIDATION

Abstract

In line with the developments in the pharmaceutical field, the product range is constantly being renewed and diversified. New analytical techniques need to be developed and validated for new pharmaceutical products. The validation of an improved method is an internationally recognized scientific requirement, as these validation practices are also indicative of the competence of the analytical laboratory. The method development is a process that ensures the applicability and reliability of the data. The result is a more comprehensive understanding of the standard test methods and a further insight into the connection between test methodology and product quality. It is important to validate an advanced method. Because if the method can not be reproduced, the method is meaningless. Validation is  a continuous balance among costs, risks and technical possibilities.


Peer Review History:


Received 5 February 2020;   Revised 22 February; Accepted 1 March, Available online 15 March 2020


UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency.


Received file


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Average Peer review marks at initial stage: 6.0/10


Average Peer review marks at publication stage: 7.5/10


Reviewer(s) detail:


Name: Kian Navaee


Affiliation: Shahre Daru Pharmaceutical Co., Iran


E-mail: kian.navaee@chemist.com


 


Name: Dr. Mohammad Shaheen Khan


Affiliation: University Malaysia Sabah, Malaysia


E-mail: shaheenchem@gmail.com


Comments of reviewer(s):


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Keywords: Medicines, quality, test method, validation
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How to Cite
BESKAN, U., S. T. YILDIRIM, and E. A. YAPAR. “AN OVERVIEW OF ANALYTICAL METHOD VALIDATION”. Universal Journal of Pharmaceutical Research, Vol. 5, no. 1, Mar. 2020, doi:https://doi.org/10.22270/ujpr.v5i1.362.
Section
Review Articles