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Доклиническая и клиническая сопоставимость биотехнологических лекарственных п...PHARMADVISOR
[Guideline on Comparability of Biotechnology-derived Medicinal Products After a Change in The Manufacturing Process Non-clinical and Clinical Issues]
Руководство по сопоставимости биотехнологических лекарственных препаратов после изменения процесса производства: доклинические и клинические вопросы
Доклиническая и клиническая сопоставимость биотехнологических лекарственных п...PHARMADVISOR
[Guideline on Comparability of Biotechnology-derived Medicinal Products After a Change in The Manufacturing Process Non-clinical and Clinical Issues]
Руководство по сопоставимости биотехнологических лекарственных препаратов после изменения процесса производства: доклинические и клинические вопросы
DRAWBACKS
Redistribution of metals
Essential metal loss
No removal of metal from intracellular space
Hepatotoxicity and Neurotoxicity
Poor clinical recovery
Pro-oxidant effects(DTPA)
Increased blood pressure
DRAWBACKS
Redistribution of metals
Essential metal loss
No removal of metal from intracellular space
Hepatotoxicity and Neurotoxicity
Poor clinical recovery
Pro-oxidant effects(DTPA)
Increased blood pressure