临床试验研究设计终点和生物标志物药物安全性

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临床试验研究设计终点和生物标志物药物安全性 890条(本栏目收费,不能显示细节,电话13136136841)

data manager,441–442 441 442

grading,442–443 442 443

missing data examples,443–444 443 444

overview,440–441 440 441

post-marketing report CIOMS I form,450–451 450 451

MedWatch form,448–450 448 450

surveillance,451–452 451 452

overview,415–417 415 417

paradoxical adverse drug reactions bronchial constriction drugs,440 440

cancer chemotherapy,437–438 437 438

growth factor therapy,438–439 438 439

depression drugs,439 439

overview,436 436

supportive/palliative care in placebo arm,136 136

Van Cutsem study,230–234 230 234

Common Technical Document (CTD),591–594 591 594

Consent forms administrative law,535,538–539,541–543 535 538 539 541 543

analysis by medical community,552 552

case law,541 541

Coyne study informed consent form,550–551 550 551

decision aids,556–558 556 558

ethics,540 540

Form E1594,544–549 544 549

Guidance for Industry E6,539–540,551 539 540 551

language level,543–544,553–555 543 544 553 555

package insert comparison,573 573

Phase I trials,555–556 555 556

stopping treatment versus withdrawing from study,558 558

Yellow Fever Commission,536–537 536 537

overall survival comparison,254–255 254 255

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