Authors: Sulaiman Mujoobe
ABSTRACT: The main purpose of this paper is to attempt to give a detailed step by step explanation of how data is collected and statistically treated during an analytical method development and validation protocol for Quality Control of Pharmaceutics. In most cases, modification to a given manufacturing process, formulation or synthetic pathway during a drug development program may necessitate changes to existing analytic methods. As a consequence, this change may require additional transfer and or validation studies. Effective method development in a pharmaceutical industry is aimed at ensuring that analytical methods meet the objectives required at each stage of drug development using the least resources available of which developmental time and cost are the main targets. Method validation involves demonstrating that these methods are suitable for their intended use as required by regulatory agencies. Method transfer is the formal process of assessing the suitability of methods in another laboratory. These studies involve numerous steps taken, according to a given Standard Operating Procedure (SOP) to collect data. Data analysis usually encompasses confusing mathematical manipulations that may require extensive knowledge of statistics. Although most papers and articles on method development and validation indicate how data is collected, very few give the final acceptance result and show how it was calculated. This paper therefore fills this gap by illustrating, following a hypothetical Standard Operating Procedure: MUJ-256-B dated 16th July 2015 from a hypothetical JBXY Pharmaceuticals, how to develop and validate a method to identify and quantitatively determine the concentration of the active pharmaceutical ingredient; (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl) methyl]-4H-carbazol-4 one, monohydrochloride, dihydrate (Ondansetron hydrochloride dihydrate) in Ondansetron hydrochloride 4mg/5ml Syrup (Nausetron) by Reversed-Phase High Performance Liquid Chromatography. Keywords: Acceptance Criteria, Hypothesis Testing, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Method Transfer; Ondansetron; Pharmaceutical; Statistics; Reversed-Phase; Biostatistics; Statistical Treatment; Quality Assurance; Quality Control.
Comments: 36 Pages. CC-BY LICENCE: Anyone can share, reuse, remix, or adapt this material for any purpose, providing the original authors are credited and cited.
[v1] 2018-02-08 09:24:00
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