2287 related articles for article (PubMed ID: 25175054)
21. 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]
22. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2008 Feb; 73(35):9575-6. PubMed ID: 18677819
[TBL] [Abstract][Full Text] [Related]
23. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
Dejas-Eckertz P; Schäffner G
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
[TBL] [Abstract][Full Text] [Related]
24. The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing.
Breslow LH
Harvard J Legis; 2003; 40(1):133-93. PubMed ID: 16594116
[TBL] [Abstract][Full Text] [Related]
25. [Objectives and organization of the International Conference on Harmonization].
Juillet Y
Ann Pharm Fr; 1999 Mar; 57(2):137-42. PubMed ID: 10365469
[TBL] [Abstract][Full Text] [Related]
26. [Contribution of explanatory notes. Efficacy of the ICH plan for international clinical development of a new drug].
Husson JM
Ann Pharm Fr; 1999 Mar; 57(2):153-60. PubMed ID: 10365472
[TBL] [Abstract][Full Text] [Related]
27. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
Senderowicz AM; Pfaff O
Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
[TBL] [Abstract][Full Text] [Related]
28. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
29. Anticancer Drug Development: The Way Forward.
Connors T
Oncologist; 1996; 1(3):180-181. PubMed ID: 10387985
[TBL] [Abstract][Full Text] [Related]
30. International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2012 Feb; 77(34):9948-9. PubMed ID: 22379685
[TBL] [Abstract][Full Text] [Related]
31. The evolution of legislation to regulate pediatric clinical trials: Present and continuing challenges.
Gans-Brangs KR; Plourde PV
Adv Drug Deliv Rev; 2006 Apr; 58(1):106-15. PubMed ID: 16530291
[TBL] [Abstract][Full Text] [Related]
32. International Conference on Harmonisation; guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human Use; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2012 Jun; 77(110):33748-9. PubMed ID: 22675782
[TBL] [Abstract][Full Text] [Related]
33. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for use in the International Conference on Harmonisation Regions; Annex 4C on Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2009 Apr; 74(66):15992-3. PubMed ID: 19507323
[TBL] [Abstract][Full Text] [Related]
34. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2004 Feb; 69(24):5551-2. PubMed ID: 14968802
[TBL] [Abstract][Full Text] [Related]
35. Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
Rivera DR; Hartzema AG
Ann Pharmacother; 2014 Mar; 48(3):369-79. PubMed ID: 24311725
[TBL] [Abstract][Full Text] [Related]
36. Performing phase I clinical trials of anticancer agents: perspectives from within the European union and Japan.
Forster MD; Saijo N; Seymour L; Calvert H
Clin Cancer Res; 2010 Mar; 16(6):1737-44. PubMed ID: 20215555
[TBL] [Abstract][Full Text] [Related]
37. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2010 Jan; 75(13):3471-2. PubMed ID: 20349552
[TBL] [Abstract][Full Text] [Related]
38. Characteriation of clinical data packages using foreign data in new drug applications in Japan.
Tanaka M; Nagata T
Clin Pharmacol Ther; 2008 Sep; 84(3):340-6. PubMed ID: 17786162
[TBL] [Abstract][Full Text] [Related]
39. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7 on Dissolution Test General Chapter; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2010 Apr; 75(64):17148-9. PubMed ID: 20383923
[TBL] [Abstract][Full Text] [Related]
40. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 9 on Tablet Friability General Chapter; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2010 Apr; 75(64):17147-8. PubMed ID: 20383922
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
