According to Gottschalk (and Kelley), the FDA may allow certain process changes to be managed under comparability protocols without clinical trials when:

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Question restatement: According to Gottschalk (and Kelley), the FDA may allow certain process changes to be managed under comparability protocols without clinical trials when:

Option A: 'The process change improves yield, and the impurity profile is unchanged' This option focuses on yield improvement and unchanged impurity profile. While maintaining impurity profile can be relevant, the key FDA comparability framework under Gottschalk and Kelley emphasizes safety, potency/efficacy, and characterization of the product. An improvement in yield alone does not automatically justify bypassing clinical trials; the safety/efficacy parameters must remain unaffected and the product must be well characterized. This makes the statement incomplete or not the standard condition described for comparability without clinical trials.

Option B: 'The process change occurs during Phase I development and is supported by in vitro assays' Here, the placement during Phase I and reliance on in vitro assays suggest early research-stage justification. However, the comparability protocol exception typically applies when changes do not affect safety, potency, or efficacy and when the product is well characterized, rather than relying on early-phase development timelines or solely in vitro data. The emphasis on clinical trial exclusion is not correctly framed by this option.

Option C: 'The process change has no impact on product safety, potency, or efficacy, and the product is well characterized' This option aligns with the core idea of comparability protocols: a change is allowable without new clinical trials if it does not alter safety, potency, or efficacy and the product remains well characterized. This reflects the regulatory concept that changes are acceptable under comparability if the critical quality attributes and clinical performance are preserved and the product is thoroughly characterized.

Option D: 'The process change reduces COGs, and the product is well characterized' While reducing cost of goods (COGs) is economically beneficial, it does not in itself justify omitting clinical trials under a comparability protocol. The regulatory justification hinges on maintaining safety, potency, and efficacy, not cost reductions. Therefore, this option fails to capture the essential regulatory criterion.

Summary of reasoning: The pivotal criterion for allowing certain process changes under comparability protocols without conducting new clinical trials is that the change must not impact safety, potency, or efficacy, and the product must be well characterized. Options A and B address some operational or developmental aspects but do not satisfy the strict condition described. Option D emphasizes cost benefits rather than preserving clinical characteristics, which is misaligned with the regulatory intent. Option C directly states the condition that matches the comparability principle as described by Gottschalk and Kelley, making it the correct alignment with the regulatory concept.

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According to Gottschalk (and Kelley), the FDA may allow certain process changes to be managed under comparability protocols without clinical trials when:

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