•植物药物/制剂4344 要求新申请需要以下内容•AP-CSP(99)4提案+相关文件•新申请表“Application form new”()•英文文件或法文文件(1份)•指导原则的注意事项(ICH 和CHMP/CVMP)-化学制品纯度:详见“文件内容”(2005)代替AP--对活性物质的要求进行概述(CHMP)CSP(99) 4的附件1 : -杂质检测(ICH Q3A...
Route Selection Drug Solid-State Research Service Solid Form Screening Service Green Chemistry Platform Production Process Optimization Clinical Sample Production Impurity Traceability & Control Generic Drug Process Study & Filing Innovative Drug Process Study & Filing Pharmaceutical preparation Analytical Metho...
(I) A schematic summary showing that both in-vitro (porcine lung endothelial cells) and in-vivo (the porcine lung disease model, ARDS) both endogenous and exogenous NO downregulate sGC protein and activity. Representative full-length blots are presented in Supplementary Figure S4. Full size ...
GMP and VMD licensed facilities specialising in formulating including API's.We operate a full pharmaceutical quality system with the support of a QP and several contract laboratories.Formulation is not just about achieving the right blend of chemicals it is about having the experience to achieve the...
8. Please add justified specifications for the full range of particle sizedistribution. Alternatively,...
b) Excipients described in a third country pharmacopoeia 第三国药典中收载的辅料 c) Excipients not ...
In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the...