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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
The EBF has also reached out to participate in international scientific meetings representing the bioanalytical voice of the European pharmaceutical industry. Selective examples are: American Association of Pharmaceutical Scientists meetings, The Boston Society Applied Pharmaceutical Analysis meetings, and Canadian Validation Group meeting.
In analytical chemistry, cross-validation is an approach by which the sets of scientific data generated using two or more methods are critically assessed. [1] The cross-validation can be categorized as either method validation [ 1 ] or analytical data validation.
Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Prospective validation – the missions conducted before new items are released to make sure the characteristics of the interests which are functioning properly and which meet safety standards. [17] [18] Some examples could be legislative rules, guidelines or proposals, [19] [20] [21] methods, [22] theories/hypothesis/models, [23] [24] products ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
Bioanalytical laboratories often deal with large numbers of samples, for example resulting from clinical trials. As such, automated sample preparation methods and liquid-handling robots are commonly employed to increase efficiency and reduce costs.