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.
124 related articles for article (PubMed ID: 9890529)
1. Process validation. Beatrice MG Dev Biol Stand; 1998; 96():169-71; discussion 177-9. PubMed ID: 9890529 [No Abstract] [Full Text] [Related]
2. 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]
3. 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]
4. The quality control of biotechnology products. Federici MM Biologicals; 1994 Jun; 22(2):151-9. PubMed ID: 7917231 [No 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. 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]
8. 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]
9. CBER: new approaches to biological product testing. Donlon JA Dev Biol Stand; 1999; 101():21-5. PubMed ID: 10566770 [TBL] [Abstract][Full Text] [Related]
10. 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]
11. Validation of tests methods in the quality control of biologicals. Hendriksen CF Dev Biol Stand; 1999; 101():217-21. PubMed ID: 10566796 [TBL] [Abstract][Full Text] [Related]
12. 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]
13. Process validation for manufacturing of biologics and biotechnology products. Proceedings of a meeting. September 6-7, 2001. Berlin, Germany. Dev Biol (Basel); 2003; 113():3-120. PubMed ID: 15116735 [No Abstract] [Full Text] [Related]
14. Strategies for the validation of viral inactivation in biologic products. Aronson DL Prog Clin Biol Res; 1990; 324():137-49. PubMed ID: 2408050 [No Abstract] [Full Text] [Related]
15. 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]
16. 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]
17. Validation of removal of human retroviruses. Marcus-Sekura CJ Dev Biol Stand; 1992; 76():215-23. PubMed ID: 1478339 [No Abstract] [Full Text] [Related]
18. 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]
19. 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]
20. Introduction to the issues: appropriate methods of process validation. Scribner CL Dev Biol Stand; 1992; 76():213-4. PubMed ID: 1478338 [No Abstract] [Full Text] [Related] [Next] [New Search]