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5. Considerations in performing virus spiking experiments and process validation studies. Darling AJ. Dev Biol Stand; 1993; 81():221-9. PubMed ID: 8174806 [Abstract] [Full Text] [Related]
6. EEC regulatory document. Note for guidance. Validation of virus removal and inactivation procedures. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines. Biologicals; 1991 Jul; 19(3):247-51. PubMed ID: 1954007 [No Abstract] [Full Text] [Related]
9. Process scale considerations in evaluation studies and scale-up. Walter JK, Werz W, Berthold W. Dev Biol Stand; 1996 Jul; 88():99-108. PubMed ID: 9119169 [Abstract] [Full Text] [Related]
12. Chromatographic removal of viruses from plasma derivatives. Burnouf T. Dev Biol Stand; 1993 Jul; 81():199-209. PubMed ID: 8174804 [Abstract] [Full Text] [Related]
13. Strategies for the validation of viral inactivation in biologic products. Aronson DL. Prog Clin Biol Res; 1990 Jul; 324():137-49. PubMed ID: 2408050 [No Abstract] [Full Text] [Related]
14. Viral safety of biological products and the concept of validation. Horaud F. Dev Biol Stand; 1996 Jul; 88():19-24. PubMed ID: 9119135 [No Abstract] [Full Text] [Related]
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16. Affinity chromatography to remove viruses during preparation of plasma derivatives. Lawrence JE. Dev Biol Stand; 1993 Jul; 81():191-7. PubMed ID: 8174803 [Abstract] [Full Text] [Related]
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