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" Guidelines on the quality, safety and efficacy of medicinal products for human use, 1989, p 103. "
Microbiological Quality Assurance: A Guide Towards Relevance and ... - Pagina 244
a cura di - 1995 - 320 pagine
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Drug Biotechnology Regulation: Scientific Basis and Practices

Y. Chiu - 1991 - 600 pagine
...authorizations for medicinal products for human use in the member states of the European Community Volume 3: Guidelines on the quality, safety and efficacy of medicinal products for human use Volume 4: Guide to good manufacturing practice for medicinal products Volume 5: The rules governing...
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Clinical Measurement in Drug Evaluation

Nimmo/Tucker - 1991 - 240 pagine
...the European Community. The Rules Governing Medicinal Products in the European Community, Volume HI: Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use, EEC, Brussels, 1989. 15 Dashwood, RH and Combes, RD Deficiencies in the covalent binding index (CBI)...
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European Medicines Research: Perspectives in Pharmacotoxicology and ...

G. N. Fracchia - 1994 - 434 pagine
...European Community. The rules governing medicinal products in the European Community, vol II and III; Guidelines on the quality, safety and efficacy of medicinal products for human use. Addendum July 1990, CB55-89843 ENC, Brussels. 28. Shindo H., Caldwell J. Regulatory aspects of the...
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Good Manufacturing Practice in Transfusion Medicine: Proceedings of the ...

C.Th. Smit Sibinga, P.C. Das, H.J. Heiniger - 1994 - 328 pagine
...for human use in the Member States of the Community. Volume II. Catalogue number CB-55-89-293-EN-C. Guidelines on the quality, safety and efficacy of medicinal products for human use. Volume III. Catalogue number CB-55-89-843-EN-C. Addendum (July 1990) CB-59-90-936-EN-C. Addendum No....
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Development and Validation of Analytical Methods

Christopher M. Riley, Thomas W. Rosanske - 1996 - 349 pagine
...US Food and Drug Administration, Fifth Revision, (1985) 11. Commission of the European Communities, "Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use", (1990) 12. Guideline for Submitting Samples and Analytical Data for Methods Validation, US Food and...
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Mammalian Cell Biotechnology in Protein Production

Hansjörg Hauser, Roland Wagner - 1997 - 520 pagine
...Retroviral Clearance. In: Separations For Biotechnology 2, SCI, Elsevier Applied Science, London-New York. Commission of the European Communities (1989) Guidelines...and Efficacy of Medicinal Products for Human Use, Vol. 2 of The Rules Governing Medicinal Products in the European Community. Commission of the European...
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Handbook of Developmental Toxicology

Ronald D. Hood - 1996 - 794 pagine
...European Economic Community, The Rules Governing Medicinal Products in the European Community, Vol. 1ll, Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use, Office of Official Publications of the European Communities, Brussels, 1988. Great Britain/ United...
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Pharmacetical Applications in the European Union: A Guide Through the ...

Cheng Yee Lowe - 1998 - 286 pagine
...Products for Human Use in Member States of the European Community. Revised and completed edition, January 1989, Guidelines on the Quality, Safety, and Efficacy of Medicinal Products for Human Use. January 1989, Addendum, July 1990. Addendum 2, May 1992. Addendum 3, January 1995, Good Manufacturing...
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Focus on Pharmaceutical Research

José Luis Valverde, G. N. Fracchia - 1999 - 108 pagine
...European Union", Office for Official Publications of the European Communities (In particular Vol. III - Guidelines on the quality, safety and efficacy of medicinal products for human use). [3] European Agency for the Evaluation of Medicinal Products - First General Report, EMEA, 1995, ISBN...
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NMR Spectroscopy in Drug Development and Analysis

Ulrike Holzgrabe, Iwona Wawer, Bernd Diehl - 1999 - 332 pagine
...detailed breakdown of the structure of a European regulatory dossier. Vol. 3 of the Rules comprises Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use and is a compilation of the notes for guidance produced by the CPMP through its Working Parties or...
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