the harmonized international protocol presents a comprehensive plan for assessing the effect of a proposed change, or multiple (related and consequential) CMC-only post-approval changes, on the quality of a product – e.g., its identity, strength, purity, potency, pe...
Improvements in Kmax and stability in visual acuity were observed over 24months in children and adults with progressive KCN or post-refractive ectasia.doi:10.1007/s40123-020-00306-1Derick O. AnsahThe Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, USAJiangxia Wang...
应当是制剂上市批准之后，对于原料药应当是获得CEP证书后