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THE PHARMA REVIEW (MARCH - APRIL 2017)

Role of Normal Error Curve in Pharmaceuticals

N.P. Sneha, K. Venu, R. Manohar, B. Gayathri & Dr. Bayya Subba Rao*

Introduction: When a drug regulatory authority asks for statistics in a pharmaceutical manufacturing industry, it is not the previous batches data of the various attributes of a drug product indicating pharmacopoeial compliance but it is the establishment of statistical methods and ensuring the sample drawn from a batch is statistically significant with quality attributes for the entire batch. The current article is an attempt in establishing statistics at the root level limiting to production levels. 

 

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