These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
162 related articles for article (PubMed ID: 9890530)
1. Relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products. Lubiniecki AS Dev Biol Stand; 1998; 96():173-5; discussion 177-9. PubMed ID: 9890530 [No Abstract] [Full Text] [Related]
2. Process validation. Beatrice MG Dev Biol Stand; 1998; 96():169-71; discussion 177-9. PubMed ID: 9890529 [No Abstract] [Full Text] [Related]
3. The quality control of biotechnology products. Federici MM Biologicals; 1994 Jun; 22(2):151-9. PubMed ID: 7917231 [No Abstract] [Full Text] [Related]
4. Philosophy and goals of validation for biotech products and the relevance of scale. Hageman TC Dev Biol Stand; 1992; 76():231-7. PubMed ID: 1478341 [TBL] [Abstract][Full Text] [Related]
5. Experience with validation of clinical trial materials: an inspector's viewpoint. Wolfe L Dev Biol (Basel); 2003; 113():27-33. PubMed ID: 14620849 [TBL] [Abstract][Full Text] [Related]
6. European Regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products. Celis P; Silvester G Dev Biol (Basel); 2004; 118():3-10. PubMed ID: 15645667 [TBL] [Abstract][Full Text] [Related]
7. Definition of a well-characterized biotechnology product. Zoon K; Garnick R Dev Biol Stand; 1998; 96():191-7. PubMed ID: 9890531 [No Abstract] [Full Text] [Related]
8. CBER: new approaches to biological product testing. Donlon JA Dev Biol Stand; 1999; 101():21-5. PubMed ID: 10566770 [TBL] [Abstract][Full Text] [Related]
9. Control of recombinant DNA produced pharmaceuticals by a combination of process validation and final product specifications. Jones AJ; O'Connor JV Dev Biol Stand; 1985; 59():175-80. PubMed ID: 4007276 [TBL] [Abstract][Full Text] [Related]
10. Note for guidance. Guidelines for medicinal products derived from human blood and plasma. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines. Biologicals; 1992 Jun; 20(2):159-64. PubMed ID: 1389112 [No Abstract] [Full Text] [Related]
11. The control of biological medicinal products produced by recombinant DNA technology. Griffiths E Dev Biol Stand; 1985; 59():155-9. PubMed ID: 4007273 [TBL] [Abstract][Full Text] [Related]
12. The preparation and validation of stock cultures of mammalian cells. Facklam TJ; Geyer S Bioprocess Technol; 1991; 13():54-85. PubMed ID: 1367151 [TBL] [Abstract][Full Text] [Related]
13. Minimum safety requirements for preclinical testing. Dorner F; Barrett PN; Schwartz HP; Eibl H Dev Biol Stand; 1993; 81():245-52. PubMed ID: 8174809 [TBL] [Abstract][Full Text] [Related]
14. Viral safety evaluation of plasma-derived therapeutic products. Farshid M Dev Biol (Basel); 2004; 118():11-5. PubMed ID: 15645668 [TBL] [Abstract][Full Text] [Related]
15. Evaluation of potency for well characterized biotechnology proteins. Finbloom DS Dev Biol Stand; 1998; 96():63-4. PubMed ID: 9890518 [No Abstract] [Full Text] [Related]
16. Well-characterized biotechnology products: evolving to meet the needs of the 21st century. Zoon KC Dev Biol Stand; 1998; 96():3-8. PubMed ID: 9890510 [No Abstract] [Full Text] [Related]
17. Evaluation of product comparability. Builder SE Dev Biol Stand; 1998; 96():83-90. PubMed ID: 9890520 [No Abstract] [Full Text] [Related]
18. Product development of probiotics as biological drugs. Sutton A Clin Infect Dis; 2008 Feb; 46 Suppl 2():S128-32; discussion S144-51. PubMed ID: 18181718 [TBL] [Abstract][Full Text] [Related]
19. Applicability of statistical reliability methods to the validation process. Koch GG Dev Biol Stand; 1992; 76():225-9. PubMed ID: 1478340 [TBL] [Abstract][Full Text] [Related]
20. Validation of virus removal in large scale purification processes. Fritsch E Dev Biol Stand; 1992; 76():239-48. PubMed ID: 1478342 [No Abstract] [Full Text] [Related] [Next] [New Search]