Tag Archive
The following is a list of all entries tagged with ICH Q4B:
Drug Regulators, EMEA, Publish ICH Q4B, Annex 10, Polyacrylamide Gel Electrophoresis General Chapter Guidance
Filed in manufacturing, December 31, 2009, 10:54 amThis annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators, EMEA, Publish ICH Q4B Annex 12, Analytical Sieving General Chapter Guidance
Filed in manufacturing, December 30, 2009, 10:50 amThis annex is the result of the Q4B process for the Analytical Sieving General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators, EMEA, Publishes ICH Q4B Annex 11, Capillary Electrophoresis General Chapter Guidance
Filed in manufacturing, December 29, 2009, 10:47 amThis annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Regulators Publish, ICH Q4B, Annex 7 Dissolution Test General Chapter Guidance
Filed in manufacturing, December 24, 2009, 11:00 amThis annex is the result of the Q4B process for Dissolution Test. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Development Regulations – Q4B Annex
Filed in formulation, regulatory, July 16, 2009, 9:38 amEMEA publishes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER(EMEA/CHMP/ICH/379801/2009)
Rapid Drug Discovery and Development Facilitated by ICH
Filed in clinical, formulation, manufacturing, pre-clinical, regulatory, July 8, 2009, 9:07 amThe International Conference on Harmonisation of Technical Requiremtns for REgistration of Pharmacetucials for Human use, steering committee and expert working groups met in Yokohama in June (6th to 11th) and a number of highlights are outlined below
Entries