临床试验药物安全性 1506条(本栏目收费,不能显示细节,电话15274084725)
degree of certainty,229 229
primary objective of the study,228 228
treatment effect expected,229 229
statistical methods for determining trial size,231 231
statistical terms commonly used in sample size calculations,230 230
superiority analysis versus non-inferiority analysis,223,226 226
time to event variables,239,241 241
two-tailed test,212,214 214
writing a sample size section of a clinical study protocol,244,245 245
Astrocytoma everolimus for,165 165
Atherosclerosis C-reactive protein as biomarker,398,400 400
package insert of,698,699 699
Add-on design active control,59,60 60
Adjuvant therapy chronic drug administration,327 327
metastasis risk reduction,326,327 327
meanings of adjuvant,327,328 328
Adverse drug reaction (ADR),70,71,79,104,105,108,136,162 162
Adverse event (AE) abnormal laboratory values,493 494 493 494
adverse drug reaction,494 494
anticipation in clinical study design,487 487
cause-and-effect data from raw data,522,523 523
anticipated versus unanticipated,500,502 502
drug induction,495,496 496
statistician considerations,496 496