184 related articles for article (PubMed ID: 15603183)
1. 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]
2. 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]
3. 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]
4. Emerging melanoma vaccines.
Bystryn JC; Rudolph JL
Expert Opin Emerg Drugs; 2005 May; 10(2):393-402. PubMed ID: 15934874
[TBL] [Abstract][Full Text] [Related]
5. Lessons learned from independent central review.
Ford R; Schwartz L; Dancey J; Dodd LE; Eisenhauer EA; Gwyther S; Rubinstein L; Sargent D; Shankar L; Therasse P; Verweij J
Eur J Cancer; 2009 Jan; 45(2):268-74. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
6. Cancer vaccines: clinical development challenges and proposed regulatory approaches for patient access to promising treatments.
Stebbing J; Wood C; Atkins M; Bukowski R; Litwin S; Bower M; Parsa A; Levitsky H
Cancer; 2008 Mar; 112(5):955-61. PubMed ID: 18286505
[TBL] [Abstract][Full Text] [Related]
7. 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]
8. Assuring the quality, safety, and efficacy of DNA vaccines.
Robertson JS; Griffiths E
Methods Mol Med; 2006; 127():363-74. PubMed ID: 16988466
[TBL] [Abstract][Full Text] [Related]
9. Regulatory harmonization--a vaccine industry perspective.
Goodrich TD
Dev Biol Stand; 1997; 90():355-61. PubMed ID: 9270864
[TBL] [Abstract][Full Text] [Related]
10. Non-clinical development of cancer vaccines: regulatory considerations.
Chabicovsky M; Ryle P
Regul Toxicol Pharmacol; 2006 Apr; 44(3):226-37. PubMed ID: 16460857
[TBL] [Abstract][Full Text] [Related]
11. Potency assays for therapeutic live whole cell cancer vaccines.
Petricciani J; Egan W; Vicari G; Furesz J; Schild G
Biologicals; 2007 Apr; 35(2):107-13. PubMed ID: 16882459
[TBL] [Abstract][Full Text] [Related]
12. Challenges associated with the development, manufacturing, and delivery of cellular medicines.
Preti RA
Cancer J; 2001; 7 Suppl 2():S62-6. PubMed ID: 11777266
[TBL] [Abstract][Full Text] [Related]
13. Difficulties associated with the development and licensing of vaccines for protection against bio-warfare and bio-terrorism.
Langford MJ; Myers RC
Dev Biol (Basel); 2002; 110():107-12. PubMed ID: 12477313
[TBL] [Abstract][Full Text] [Related]
14. Characterization of polyvalent allogeneic vaccines.
Van Epps D
Dev Biol (Basel); 2004; 116():79-90; discussion 133-43. PubMed ID: 15603185
[TBL] [Abstract][Full Text] [Related]
15. Advancing TB vaccines to Phase I clinical trials in the US: regulatory/manufacturing/licensing issues.
Rowland SS; Mayner RL; Barker L
Tuberculosis (Edinb); 2005; 85(1-2):39-46. PubMed ID: 15687026
[TBL] [Abstract][Full Text] [Related]
16. Lessons from preventive infectious disease vaccines.
Chandler DK; Midthun K; Goldenthal KL
Dev Biol (Basel); 2004; 116():61-6; discussion 69-76. PubMed ID: 15603184
[TBL] [Abstract][Full Text] [Related]
17. Characterization of tumor vaccines during product development.
Razzaque A; Dye E; Puri RK
Vaccine; 2000 Nov; 19(6):644-7. PubMed ID: 11090716
[TBL] [Abstract][Full Text] [Related]
18. [Cancer vaccines].
Kyte JA
Tidsskr Nor Laegeforen; 2006 Nov; 126(22):2969-73. PubMed ID: 17117197
[TBL] [Abstract][Full Text] [Related]
19. The history and contemporary challenges of the US Food and Drug Administration.
Borchers AT; Hagie F; Keen CL; Gershwin ME
Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
[TBL] [Abstract][Full Text] [Related]
20. Gene transfer: regulatory issues and their impact on the clinical investigator and the good manufacturing production facility.
Grilley BJ; Gee AP
Cytotherapy; 2003; 5(3):197-207. PubMed ID: 12850787
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]