Certain tests may apply to special grades (parenteral, dialysis solutions, etc.) or a test may have a special limit for a particular use: this is indicated within the test. 某些检查可能适用于特殊剂型(肠外,透析溶液等),或者某项检查可能对某一特定用途有 特定的限度:应在该检查中注明. II.7.2....
EMA/CHMP/600958/2010/Corr.* Committee of Medicines for Human Use (CHMP) Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1):Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1 Draft agreed by Pharmacokinetics Working Party January...