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13136136841)

biologics vs. chemical drugs,416–417 416 417

case study drug development,420 420

errors,419–420 419 420

EU market experience,427 427

exclusivity,418–420 418 420

generics,421–422 421 422

implications,434–436 434 436

incentives for biosimilars,428 428

incentivizing market acceptance,431–432 431 432

innovation benefits,415–416 415 416

interchangeability,426–427 426 427

introduction,414 414

market opportunities,429 429

Medicare,432–433 432 433

naming controversy,433 433

patent dance,423–424 423 424

patent protection,418–419 418 419

reimbursement issues,431 431

risk and reward,417–418 417 418

savings from biosimilars,427–428 427 428

summary,434–436 434 436

terminology,414–415 414 415

US biosimilar submissions,430–431 430 431

competitive ligand binding assay (CLBA),337 337

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

complementary determining regions (CDRs),113 113

complement-dependent cytotoxicity (CDC),179 179

confirmation,205–206,340–341 205 206 340 341

consistency,7,31–40 7 31 40

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

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