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Abstract
To improve the way by which the quality control of medicines is carried out, general statistical concepts and methods are discussed for the evaluation of the analytical results obtained for judging the adequacy of drug substances and products for Pharmacopoeia requirements.
Statistical procedures to be adopted by the producer and the controller in the determination of characteristics are suggested when the drug substance is or is not homogeneous and when the precision of the analytical method is known or unknown.
For each of these cases, detailed numerical examples are given.