306 related articles for article (PubMed ID: 11709773)
1. Vaccine industry perspective of current issues of good manufacturing practices regarding product inspections and stability testing.
Monahan TR
Clin Infect Dis; 2001 Dec; 33 Suppl 4():S356-61. PubMed ID: 11709773
[TBL] [Abstract][Full Text] [Related]
2. Manufacturing issues with combining different antigens: a regulatory perspective.
Falk LA; Arciniega J; McVittie L
Clin Infect Dis; 2001 Dec; 33 Suppl 4():S351-5. PubMed ID: 11709772
[TBL] [Abstract][Full Text] [Related]
3. Preparing for an FDA preapproval inspection.
Blackmer RA
Qual Assur; 1994 Dec; 3(4):389-403. PubMed ID: 7613749
[TBL] [Abstract][Full Text] [Related]
4. Development and approval of vaccines in the United States.
Botstein P
Isr J Med Sci; 1986; 22(3-4):268-71. PubMed ID: 3528047
[TBL] [Abstract][Full Text] [Related]
5. Food and Drug Administration regulation and evaluation of vaccines.
Marshall V; Baylor NW
Pediatrics; 2011 May; 127 Suppl 1():S23-30. PubMed ID: 21502242
[TBL] [Abstract][Full Text] [Related]
6. Ten steps to ensure a successful preNDA approval inspection.
Justice RM; Rodriguez JO; Chiasson WJ
J Parenter Sci Technol; 1993; 47(2):89-92. PubMed ID: 8515350
[TBL] [Abstract][Full Text] [Related]
7. Manufacturing issues related to combining different antigens: an industry perspective.
Van Hoof J
Clin Infect Dis; 2001 Dec; 33 Suppl 4():S346-50. PubMed ID: 11709771
[TBL] [Abstract][Full Text] [Related]
8. Regulatory expectations during product development for tumour vaccines.
Kawakami K; Puri RK
Dev Biol (Basel); 2004; 116():53-9; discussion 69-76. PubMed ID: 15603183
[TBL] [Abstract][Full Text] [Related]
9. FDA perspective on specifications for biotechnology products--from IND to PLA.
Murano G
Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677
[TBL] [Abstract][Full Text] [Related]
10. Food and Drug Administration inspection and licensing of manufacturing facilities.
Avallone HL; Beatrice MG; Sze TT
Bioprocess Technol; 1991; 13():315-40. PubMed ID: 1367137
[No Abstract] [Full Text] [Related]
11. Current good manufacturing practices for PET drug products in the United States.
Swanson D; Graham M; Heinonen TM; Libby P; Mills GQ
J Nucl Med; 2009 Aug; 50(8):26N-8N. PubMed ID: 19652213
[No Abstract] [Full Text] [Related]
12. Review of current preclinical testing strategies for bacterial vaccines.
Falk LA; Chandler DK; Richman P
Dev Biol Stand; 1998; 95():25-9. PubMed ID: 9855411
[TBL] [Abstract][Full Text] [Related]
13. The use of total quality principles to achieve regulatory compliance in research laboratories.
Hynes MD
Qual Assur; 1995 Mar; 4(1):34-40. PubMed ID: 8520863
[TBL] [Abstract][Full Text] [Related]
14. Regulatory requirements for veterinary vaccine stability in the European Community.
Fawthrop D
Dev Biol Stand; 1996; 87():319-27. PubMed ID: 8854032
[TBL] [Abstract][Full Text] [Related]
15. Enforcement of the current good manufacturing practices for solid oral dosage forms after United States v. Barr Laboratories.
Jimenez FA
Food Drug Law J; 1997; 52(1):67-82. PubMed ID: 10346711
[No Abstract] [Full Text] [Related]
16. Regulatory harmonization--a vaccine industry perspective.
Goodrich TD
Dev Biol Stand; 1997; 90():355-61. PubMed ID: 9270864
[TBL] [Abstract][Full Text] [Related]
17. Perspectives on the manufacture of combination vaccines.
Vose JR
Clin Infect Dis; 2001 Dec; 33 Suppl 4():S334-9. PubMed ID: 11709769
[TBL] [Abstract][Full Text] [Related]
18. Characterization of gene therapy products and the impact of manufacturing changes on product comparability.
Simek SL
Dev Biol (Basel); 2005; 122():139-44. PubMed ID: 16375258
[TBL] [Abstract][Full Text] [Related]
19. Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies.
Kanesa-thasan N; Shaw A; Stoddard JJ; Vernon TM
Pediatrics; 2011 May; 127 Suppl 1():S16-22. PubMed ID: 21502248
[TBL] [Abstract][Full Text] [Related]
20. Instrumentation and radiopharmaceutical validation.
Zigler SS
Q J Nucl Med Mol Imaging; 2009 Aug; 53(4):402-10. PubMed ID: 19834450
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
