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药物成型手册 1286条(本栏目收费,不能显示细节,电话13136136841)
development phases 9,14
9 14
recombinant drugs 17,18
17 18
drug product (DP): contaminants 457
457
dissolution testing 182,183
182 183
immunochemical procedures 456
456
peptide mapping of 461
461
process controls 458,459
458 459
specifications for 460
460
stability program 449
449
stress testing 452,453
452 453
drug substance (DS) 329,330
329 330
characterization,ICH guidelines 56,57,60
56 57 60
dosage forms,study factors 330,331
330 331
and DP see drug product (DP);impurities 361,370
361 370
NanoCrystal particles 70,71
70 71