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.
262 related articles for article (PubMed ID: 14620849)
1. 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]
2. Establishing pan-European clinical trials: regulatory compliance and other practical considerations. Grienenberger A J Biolaw Bus; 2004; 7(4):58-63. PubMed ID: 15675097 [TBL] [Abstract][Full Text] [Related]
3. EU directive on clinical trials penalizes small sponsors. Meldolesi A Nat Biotechnol; 2003 Aug; 21(8):838. PubMed ID: 12894186 [No Abstract] [Full Text] [Related]
4. Barriers to clinical trials vary according to the type of trial and the institution. Govindarajan R; Young JW; Harless CL; Hutchins LF J Clin Oncol; 2007 Apr; 25(12):1633-4; author reply 1634. PubMed ID: 17443010 [No Abstract] [Full Text] [Related]
5. Validation of fermentation processes. Lubiniecki AS; Gardner AR; Smith TM; Wang WK; McAllister PR; Federici MM Dev Biol (Basel); 2003; 113():37-44; discussion 111-2. PubMed ID: 14620850 [TBL] [Abstract][Full Text] [Related]
6. New European clinical trial regulations are "unacceptable" to industry. Davidson S Nat Biotechnol; 1998 Feb; 16(2):127. PubMed ID: 9487504 [No Abstract] [Full Text] [Related]
7. Expectations for process validation: industry perspectives. Francis R Dev Biol (Basel); 2003; 113():9-14. PubMed ID: 14620847 [No Abstract] [Full Text] [Related]
8. Out in the open. Nat Biotechnol; 2005 Feb; 23(2):153. PubMed ID: 15696130 [No Abstract] [Full Text] [Related]
9. 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]
10. Canadian perspectives on expectations for process validation. Ridgway A Dev Biol (Basel); 2003; 113():3-8. PubMed ID: 14620846 [No Abstract] [Full Text] [Related]
11. Clinical trials for children with cancer in Europe - still a long way from harmonisation: a report from SIOP Europe. Pritchard-Jones K; Eur J Cancer; 2008 Oct; 44(15):2106-11. PubMed ID: 18757192 [TBL] [Abstract][Full Text] [Related]
12. [Quality requirements for investigational medicinal products. The state authorities' point of view]. Neuhaus J Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):189-95. PubMed ID: 15726460 [TBL] [Abstract][Full Text] [Related]
13. Biosimilars: opportunity or cause for concern? Roger SD; Mikhail A J Pharm Pharm Sci; 2007; 10(3):405-10. PubMed ID: 17727803 [TBL] [Abstract][Full Text] [Related]
14. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule. Food and Drug Administration, HHS Fed Regist; 2004 Nov; 69(226):68611-88. PubMed ID: 15562555 [TBL] [Abstract][Full Text] [Related]
15. Control of manufacture--principles and purposes. Luff PR Dev Biol Stand; 1992; 79():155-8. PubMed ID: 1286749 [TBL] [Abstract][Full Text] [Related]
16. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2008 Aug; 73(151):45462-3. PubMed ID: 18949880 [TBL] [Abstract][Full Text] [Related]
17. FEDESA's point of view: quality, application to IVMPs (immunological veterinary medicinal products). Soulebot JP Dev Biol Stand; 1992; 79():201-11. PubMed ID: 1286759 [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. Do natural compounds need specific drug development? Simon P; Verry M Prog Clin Biol Res; 1988; 280():407-21. PubMed ID: 3051029 [No Abstract] [Full Text] [Related]
20. Clinical programs in the development of similar biotherapeutic products: rationale and general principles. Berghout A Biologicals; 2011 Sep; 39(5):293-6. PubMed ID: 21911300 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]