240 related articles for article (PubMed ID: 8661335)
1. The timing of preclinical toxicological studies: pharmaceutical company approaches to toxicity testing in support of initial clinical investigations.
Parkinson C; Thomas KE; Lumley CE
Regul Toxicol Pharmacol; 1996 Apr; 23(2):162-72. PubMed ID: 8661335
[TBL] [Abstract][Full Text] [Related]
2. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.
Robinson S; Delongeas JL; Donald E; Dreher D; Festag M; Kervyn S; Lampo A; Nahas K; Nogues V; Ockert D; Quinn K; Old S; Pickersgill N; Somers K; Stark C; Stei P; Waterson L; Chapman K
Regul Toxicol Pharmacol; 2008 Apr; 50(3):345-52. PubMed ID: 18295384
[TBL] [Abstract][Full Text] [Related]
3. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.
EFSA GMO Panel Working Group on Animal Feeding Trials
Food Chem Toxicol; 2008 Mar; 46 Suppl 1():S2-70. PubMed ID: 18328408
[TBL] [Abstract][Full Text] [Related]
4. Anticancer Drug Development: The Way Forward.
Connors T
Oncologist; 1996; 1(3):180-181. PubMed ID: 10387985
[TBL] [Abstract][Full Text] [Related]
5. Reproductive toxicity testing of pharmaceutical compounds to support the inclusion of women in clinical trials.
Parkinson C; Thomas KE; Lumley CE
Hum Exp Toxicol; 1997 May; 16(5):239-46. PubMed ID: 9192201
[TBL] [Abstract][Full Text] [Related]
6. Safety evaluation to support First-In-Man investigations II: toxicology studies.
Baldrick P
Regul Toxicol Pharmacol; 2008 Jul; 51(2):237-43. PubMed ID: 18501490
[TBL] [Abstract][Full Text] [Related]
7. [Our policy and future tasks related to ICH in anti-cancer drug development--a discussion from the viewpoint of an enterprise].
Ekimoto H
Gan To Kagaku Ryoho; 1997 Jan; 24(2):229-37. PubMed ID: 9030236
[TBL] [Abstract][Full Text] [Related]
8. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
Reeve LM
Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
[TBL] [Abstract][Full Text] [Related]
9. Drug research: from the idea to the product.
Kuhlmann J
Int J Clin Pharmacol Ther; 1997 Dec; 35(12):541-52. PubMed ID: 9455711
[TBL] [Abstract][Full Text] [Related]
10. High dose selection in general toxicity studies for drug development: A pharmaceutical industry perspective.
Buckley LA; Dorato MA
Regul Toxicol Pharmacol; 2009 Aug; 54(3):301-7. PubMed ID: 19477212
[TBL] [Abstract][Full Text] [Related]
11. Optimising the design of preliminary toxicity studies for pharmaceutical safety testing in the dog.
Smith D; Combes R; Depelchin O; Jacobsen SD; Hack R; Luft J; Lammens L; von Landenberg F; Phillips B; Pfister R; Rabemampianina Y; Sparrow S; Stark C; Stephan-Gueldner M
Regul Toxicol Pharmacol; 2005 Mar; 41(2):95-101. PubMed ID: 15698532
[TBL] [Abstract][Full Text] [Related]
12. A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.
André FE; Foulkes MA
Dev Biol Stand; 1998; 95():57-60. PubMed ID: 9855414
[TBL] [Abstract][Full Text] [Related]
13. Exploratory clinical trials: implementation modes & guidelines, scope and regulatory framework.
Francillon A; Pickering G; Belorgey C
Therapie; 2009; 64(3):149-59. PubMed ID: 19671427
[TBL] [Abstract][Full Text] [Related]
14. Evaluation of rodent-only toxicology for early clinical trials with novel cancer therapeutics.
Newell DR; Burtles SS; Fox BW; Jodrell DI; Connors TA
Br J Cancer; 1999 Nov; 81(5):760-8. PubMed ID: 10555743
[TBL] [Abstract][Full Text] [Related]
15. Preclinical safety evaluation of monoclonal antibodies.
Lynch CM; Grewal IS
Handb Exp Pharmacol; 2008; (181):19-44. PubMed ID: 18071940
[TBL] [Abstract][Full Text] [Related]
16. 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]
17. A proposed design for conducting target animal safety studies for developing new veterinary pharmaceuticals.
Carakostas MC; Colaianne JJ
Regul Toxicol Pharmacol; 1996 Feb; 23(1 Pt 1):49-54. PubMed ID: 8628920
[TBL] [Abstract][Full Text] [Related]
18. Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States.
Wu KM; Ghantous H; Birnkrant DB
Food Chem Toxicol; 2008 Aug; 46(8):2606-10. PubMed ID: 18614266
[TBL] [Abstract][Full Text] [Related]
19. Use of the dog as non-rodent test species in the safety testing schedule associated with the registration of crop and plant protection products (pesticides): present status.
Box RJ; Spielmann H
Arch Toxicol; 2005 Nov; 79(11):615-26. PubMed ID: 15940470
[TBL] [Abstract][Full Text] [Related]
20. [Pharmacokinetic and metabolic studies in the development of drugs].
Vereczkey L
Acta Pharm Hung; 1995 Jul; 65(4):105-11. PubMed ID: 7572191
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]