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Journal Abstract Search
1165 related items for PubMed ID: 19507321
21. International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2005 Jun 30; 70(125):37861-2. PubMed ID: 15988855 [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; Annex 7 on Dissolution Test General Chapter; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2010 Apr 05; 75(64):17148-9. PubMed ID: 20383923 [Abstract] [Full Text] [Related]
23. International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2001 Oct 16; 66(200):52634-7. PubMed ID: 12358037 [Abstract] [Full Text] [Related]
24. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial texts for use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2010 Sep 02; 75(170):53873-4. PubMed ID: 20812423 [Abstract] [Full Text] [Related]
25. International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2003 Nov 21; 68(225):65717-8. PubMed ID: 14631936 [Abstract] [Full Text] [Related]
26. International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2003 Apr 02; 68(63):16060-1. PubMed ID: 12674113 [Abstract] [Full Text] [Related]
27. International Conference on Harmonisation; Guidance on S9 Nonclincal Evaluation for Anticancer Pharmaceuticals; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2010 Mar 08; 75(44):10487-8. PubMed ID: 20383918 [Abstract] [Full Text] [Related]
30. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2000 Dec 15; 65(242):78493-4. PubMed ID: 12362934 [Abstract] [Full Text] [Related]
31. International Conference on Harmonisation; guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2005 Oct 20; 70(202):61133-4. PubMed ID: 16237859 [Abstract] [Full Text] [Related]
32. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2015 Jan 27; 80(17):4282-3. PubMed ID: 25730921 [Abstract] [Full Text] [Related]
33. International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2012 May 18; 77(97):29665-6. PubMed ID: 22616137 [Abstract] [Full Text] [Related]
34. International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 1998 Sep 21; 63(182):50244-9. PubMed ID: 12269373 [Abstract] [Full Text] [Related]
35. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2001 May 14; 66(93):24390-1. PubMed ID: 12356096 [Abstract] [Full Text] [Related]
36. International Conference on Harmonisation; final recommendations on the revision of the permitted daily exposures for two solvents, n-methylpyrrolidone and tetrahydrofuran, according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; Availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2003 Nov 13; 68(219):64352-3. PubMed ID: 14619948 [Abstract] [Full Text] [Related]
37. International Conference on Harmonisation; guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2004 Jun 09; 69(111):32358-9. PubMed ID: 15188781 [Abstract] [Full Text] [Related]
38. 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 07; 77(110):33748-9. PubMed ID: 22675782 [Abstract] [Full Text] [Related]
39. International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2012 Nov 20; 77(224):69634-5. PubMed ID: 23227566 [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 10 on Polyacrylamide Gel Electrophoresis General Chapter; availability. Notice. Food and Drug Administration, HHS. Fed Regist; 2010 Apr 12; 75(69):18509-10. PubMed ID: 20387318 [Abstract] [Full Text] [Related] Page: [Previous] [Next] [New Search]