Do product-related impurity profiles need to be similar?
Of the three tables which addressed this question, two felt that impurity profiles do not need to be similar, while the third table thought this was necessary for chemical comparability. All tables agreed, however, that impurity differences should be justified and demonstrated to have no clinical impact. Sub-question VI: What would be the role of bioassays? Bioassays are seen as useful to demonstrate comparability, through confirmation of 3D, consistency in manufacturing, and comparability of biological activity. Sub-question VII: What role should PK and PD studies play? Participants say that PK/PD studies may detect any difference that affect absorption or disposition. If PD is a surrogate endpoint, then a PK/PD will provide critical information on comparable efficacy. Sub-question VIII: How much can physico-chemical methods tell you about biology? Physico-chemical methods have limited power to explain biology, according to participants. They can, however, indicate the presence of iss
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