In cases where a manufacturing change(s) results in a product with structural and/or bioactivity differences, and/or differences in pharmacokinetics patterns, and those differences are meaningful with respect to potential impact on the product's safety, purity, or potency (efficacy) - Group of answer choices Additional clinical study(ies) may be needed The manufacturing change will not be approved by FDA An animal study comparing PKPD may suffice None of the above