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Journal Abstract Search
347 related items for PubMed ID: 9737396
1. Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline. Dev Biol Stand; 1998; 93():177-201. PubMed ID: 9737396 [No Abstract] [Full Text] [Related]
2. Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline. Dev Biol Stand; 1998; 93():205-8. PubMed ID: 9737397 [No Abstract] [Full Text] [Related]
3. Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline. Dev Biol Stand; 1998; 93():223-34. PubMed ID: 9737399 [No Abstract] [Full Text] [Related]
4. Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products. Dev Biol Stand; 1998; 93():211-9. PubMed ID: 9737398 [No Abstract] [Full Text] [Related]
5. International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice. Fed Regist; 1998 Sep 24; 63(185):51074-84. PubMed ID: 10185809 [Abstract] [Full Text] [Related]
6. WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals (requirements for biological substances No 50). Dev Biol Stand; 1998 Sep 24; 93():141-71. PubMed ID: 9737395 [No Abstract] [Full Text] [Related]
7. Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents. Dev Biol Stand; 1998 Sep 24; 93():130-1. PubMed ID: 9737389 [No Abstract] [Full Text] [Related]
8. Issues related to harmonization of testing requirements for viral safety. Hayakawa T. Dev Biol Stand; 1996 Sep 24; 88():15-8. PubMed ID: 9119129 [Abstract] [Full Text] [Related]
9. Safety of biological products prepared from mammalian cell culture. Detecting viruses in cell banks. Dev Biol Stand; 1998 Sep 24; 93():129. PubMed ID: 9737388 [No Abstract] [Full Text] [Related]
10. International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 1998 Sep 21; 63(182):50244-9. PubMed ID: 12269373 [Abstract] [Full Text] [Related]
19. ICH guidelines and PhEur monographs on derivation and characterisation of cell substrates used for production of biotechnological/biological products. International Conference on Harmonisation. Dobbelaer R. Dev Biol Stand; 1999 Sep 21; 98():159-65; discussion 167. PubMed ID: 10494969 [Abstract] [Full Text] [Related]