生物仿制药产品开发

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生物仿制药产品开发 1451条(本栏目收费,不能显示细节,电话15274084725)

biologics vs. chemical drugs,416–417 417

case study drug development,420 420

errors,419–420 420

EU market experience,427 427

exclusivity,418–420 420

generics,421–422 422

implications,434–436 436

incentives for biosimilars,428 428

incentivizing market acceptance,431–432 432

innovation benefits,415–416 416

interchangeability,426–427 427

introduction,414 414

market opportunities,429 429

Medicare,432–433 433

naming controversy,433 433

patent dance,423–424 424

patent protection,418–419 419

reimbursement issues,431 431

risk and reward,417–418 418

savings from biosimilars,427–428 428

summary,434–436 436

terminology,414–415 415

US biosimilar submissions,430–431 431

competitive ligand binding assay (CLBA),337 337

complementary determining regions (CDR),115,118,179,448 448

complementary determining regions (CDRs),113 113

complement-dependent cytotoxicity (CDC),179 179

confirmation,205–206,340–341 341

consistency,7,31–40 40

cotranslational modifications (CMs),29,112–115 115

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