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 制药项目管理,药物与药学 387条(本栏目收费,不能显示细节,电话13136136841)
Key performance indicators (KPIs), 94-96 94 96 
Key project goals 
rewards for achieving and managing an international project team and, 118, 119 118  119 
L. 
Launch strategy for new products, 17-19 17 19 
postfiling and, 18, 19 18  19 
registration and, 17, 18 17  18 
Legal and regulatory requirements for project planning, 57 57 
Life-cycle strategy for new products, 19, 20 19  20 
Localized departmental IT systems, 265 265 
Local research ethics committee (LRECs), 210 210 
Manufacturing project management, 233-252 233 252 
challenges to, 234, 235 234  235 
[Manufacturing project management] 
changing demands of each phase of product development, 238-244 238 244 
full commercialization, 243 243 
molecule selection, 238, 239 238  239 
patent expiry defense strategy, 243, 244 243  244 
phase II/III, 241, 242 241  242 
phase IV/launch, 242, 243 242  243 
preclinical phase I/II, 239-241 239 241 
[Clinical trials] 
clinical project manager's authority, 223, 224 223  224 
clinical research in the new global village, 224-231 224 231 
consistent plannning, 219, 220 219  220 
integrating GCP, quality systems, and project management, 222, 223 222  223 
new approaches to written procedures, 220, 221 220  221 
projects vs. hierarchies, 216-219 216 219 
quality dimension, 221,222 221 222 
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