100 Clinical Results associated with Alcon Laboratories UK Ltd.
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0 Patents (Medical) associated with Alcon Laboratories UK Ltd.
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3
Literatures (Medical) associated with Alcon Laboratories UK Ltd.
2002·Drugs and the Pharmaceutical Sciences
European aspects of the regulation of drug products with particular reference to development pharmaceutics
Author: Matthews, Brian R.
A review and discussion. The regulatory requirements relating to data on development pharmaceutics and process validation are discussed. The discussion is limited to Marketing Authorization Applications for the European Economic Area and many central and eastern European countries. Documents used to prepare this article are listed.
2000·Drugs and the Pharmaceutical Sciences
Regulatory aspects of stability testing in Europe
Author: Matthews, Brian R.
A review with 1 references Reasons for drug stability studies, pharmaceutical expert reports, postmarketing changes, drug-device combinations, impurities in new active substances, stability testing of new drugs and products, etc., are discussed.
01 Jul 1999·Drug Development and Industrial PharmacyQ4 · MEDICINE
Regulatory aspects of stability testing in Europe
Q4 · MEDICINE
Article
Author: Matthews, Brian R.
The stability data requirements for human pharmaceuticals in the European Community (EC) are based on a series of Directive and Regulation requirements and on a series of advisory guidelines that have been developed and adopted through the International Conference on Harmonization (ICH) procedures or, where there is no relevant ICH project, through the Committee for Proprietary Medicinal Products (CPMP). There are relevant requirements that cover new drugs and finished products containing them and also for existing active ingredients and products containing them. The sources of the relevant information and the data requirements are discussed and summarized.
100 Deals associated with Alcon Laboratories UK Ltd.
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100 Translational Medicine associated with Alcon Laboratories UK Ltd.
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