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Research Article

Characterisation of Macromolecules Used as Pharmaceutical Excipients: Excipients and the Regulatory Authorities

Pages 2449-2463 | Published online: 20 Oct 2008

References

  • The Rules Governing Medicinal Products in the European Community, Volume I. The Rules Governing Medicinal Products for Human Use in the European Community, ISBN 92 825 9563 3. Office for Publications of the European Community, Luxembourg 1989, (13.50 ecu)
  • The Rules Governing Medicinal Products in the European Community, Volume 11. Notice to Applicants for Marketing Authorisations for Proprietary Medicinal Products for Human Use in the Member States of the European Community, ISBN 92 825 9503 X. Office for Publications of the European Communities, Luxembourg 1989, (15.50 ecu)
  • The Rules Governing Medicinal Products in the European Community, Volume 111. Guidelines on the Quality, Safety and Efficacy of Medicinal Products for Human Use, ISBN 92 825 9619 2. Office for Publications of the European Communities, Luxembourg 1989, (23.25 ecu)
  • Guidance Notes on Applications for Product Licences (MAL 2), ISBN 0 11 321250 X. Medicines Control Agency (Department of Health). Her Majesty's Stationery Office, London 1989

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