172 related articles for article (PubMed ID: 25484311)
21. Regulatory considerations in application of encapsulated cell therapies.
van Zanten J; de Vos P
Adv Exp Med Biol; 2010; 670():31-7. PubMed ID: 20384216
[TBL] [Abstract][Full Text] [Related]
22. A program to provide regulatory support for investigator-initiated clinical research.
Arbit HM; Paller MS
Acad Med; 2006 Feb; 81(2):146-53. PubMed ID: 16436575
[TBL] [Abstract][Full Text] [Related]
23. Recent policies that support clinical application of induced pluripotent stem cell-based regenerative therapies.
Azuma K; Yamanaka S
Regen Ther; 2016 Jun; 4():36-47. PubMed ID: 31245486
[TBL] [Abstract][Full Text] [Related]
24. Strategies for more rapid translation of cellular therapies for children: a US perspective.
Sanchez R; Silberstein LE; Lindblad RW; Welniak LA; Mondoro TH; Wagner JE
Pediatrics; 2013 Aug; 132(2):351-8. PubMed ID: 23837178
[TBL] [Abstract][Full Text] [Related]
25. Melanoma Vaccine--AVAX Technologies: DNP-VACC, M-Vax.
BioDrugs; 2003; 17(1):69-72. PubMed ID: 12534322
[TBL] [Abstract][Full Text] [Related]
26. Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Holbein ME
J Investig Med; 2009 Aug; 57(6):688-94. PubMed ID: 19602987
[TBL] [Abstract][Full Text] [Related]
27. Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP).
Manchikanti L; Centeno CJ; Atluri S; Albers SL; Shapiro S; Malanga GA; Abd-Elsayed A; Jerome M; Hirsch JA; Kaye AD; Aydin SM; Beall D; Buford D; Borg-Stein J; Buenaventura RM; Cabaret JA; Calodney AK; Candido KD; Cartier C; Latchaw R; Diwan S; Dodson E; Fausel Z; Fredericson M; Gharibo CG; Gupta M; Kaye AM; Knezevic NN; Kosanovic R; Lucas M; Manchikanti MV; Mason RA; Mautner K; Murala S; Navani A; Pampati V; Pastoriza S; Pasupuleti R; Philip C; Sanapati MR; Sand T; Shah RV; Soin A; Stemper I; Wargo BW; Hernigou P
Pain Physician; 2020 Mar; 23(2):E85-E131. PubMed ID: 32214287
[TBL] [Abstract][Full Text] [Related]
28. American Society of Clinical Oncology policy statement: oversight of clinical research.
American Society of Clinical Oncology
J Clin Oncol; 2003 Jun; 21(12):2377-86. PubMed ID: 12721281
[TBL] [Abstract][Full Text] [Related]
29. Administrative and research policies required to bring cellular therapies from the research laboratory to the patient's bedside.
Yim R
Transfusion; 2005 Oct; 45(4 Suppl):144S-58S. PubMed ID: 16181400
[TBL] [Abstract][Full Text] [Related]
30. Regulation of research: is it a drug trial or a supplement trial?
Chen ST
Fitoterapia; 2011 Jan; 82(1):14-6. PubMed ID: 21073930
[TBL] [Abstract][Full Text] [Related]
31. Phase 0 clinical trials: conceptions and misconceptions.
Kummar S; Rubinstein L; Kinders R; Parchment RE; Gutierrez ME; Murgo AJ; Ji J; Mroczkowski B; Pickeral OK; Simpson M; Hollingshead M; Yang SX; Helman L; Wiltrout R; Collins J; Tomaszewski JE; Doroshow JH
Cancer J; 2008; 14(3):133-7. PubMed ID: 18536551
[TBL] [Abstract][Full Text] [Related]
32. Regulation of Regenerative Medicine Products.
Gee AP
Adv Exp Med Biol; 2018; 1098():189-198. PubMed ID: 30238372
[TBL] [Abstract][Full Text] [Related]
33. Appropriate specifications at the IND stage.
Geigert J
Dev Biol Stand; 1997; 91():39-43. PubMed ID: 9413681
[TBL] [Abstract][Full Text] [Related]
34. Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer.
Senderowicz AM
Clin Cancer Res; 2010 Mar; 16(6):1719-25. PubMed ID: 20215544
[TBL] [Abstract][Full Text] [Related]
35. 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]
36. The basics of preclinical drug development for neurodegenerative disease indications.
Steinmetz KL; Spack EG
BMC Neurol; 2009 Jun; 9 Suppl 1(Suppl 1):S2. PubMed ID: 19534731
[TBL] [Abstract][Full Text] [Related]
37. The Regulatory Evaluation of Vaccines for Human Use.
Baylor NW
Methods Mol Biol; 2016; 1404():773-787. PubMed ID: 27076337
[TBL] [Abstract][Full Text] [Related]
38. Executive Summary of the National Cancer Institute Workshop: Highlights and recommendations.
Lieberman R; Nelson WG; Sakr WA; Meyskens FL; Klein EA; Wilding G; Partin AW; Lee JJ; Lippman SM
Urology; 2001 Apr; 57(4 Suppl 1):4-27. PubMed ID: 11295590
[TBL] [Abstract][Full Text] [Related]
39. Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?
Sheets RL; Rangavajhula V; Pullen JK; Butler C; Mehra V; Shapiro S; Pensiero M
Vaccine; 2015 Apr; 33(15):1757-66. PubMed ID: 25698494
[TBL] [Abstract][Full Text] [Related]
40. Challenges of translating a cell therapy to GMP.
Bauer G; Fury B
Int Rev Neurobiol; 2022; 166():207-234. PubMed ID: 36424093
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]