SUPAC-IR 问答-5

beiwei5du

IN VIVO BIO STUDIES

1.    Q: If the highest strength was the biobatch strength, and waivers were used for the other strengths, does supporting documentation for SUPAC-IR changes refer to all strengths? Does the answer differ depending on whether the strengths are dose/weight proportional?

1. 问题： 如果最高规格批次是生物（等效性）批次，其他批次的产品申请生物等效豁免，SUPAC-IR变更的支持文件是否适用于所有规格的产品？答案是否因不同规格的产品与剂量/重量的比而有所不同？

A: For SUPAC-IR bioequivalence recommendations, the recommended tests apply to all strengths. Regarding bio-requirements, the supporting documentation normally is needed for all strengths. If a bioequivalence study is recommended,then the compositional proportionality of the various strengths may determine if all strengths need to be tested for bioequivalence, or if a strength can be waived. However, this is not the standard comparison that is in the SUPAC-IR Guidance.

回答：对于SUPAC-IR生物等效性建议，推荐的研究适用于所有规格的产品。有关生物等效性要求，通常不同规格的所有产品都需要支持文件。如果建议进行生物等效性研究，那么根据不同规格的产品所含成分的比例关系，可确定是否需要对所有不同规格的产品进行生物等效性试验，或确定某个规格的产品是否可以豁免生物等效性研究。但这不是SUPAC-IR指导原则中的标准比较方法。

2.    Q: Will many small changes prompt the Agency to require a biostudy?

2.问题：如果有许多微小的变更，FDA 是否会因此要求进行生物等效性研究？

A: Generally, a biostudy will not be requested simply because many changes which individually would not normally require a biostudy, are performed.

回答：一般情况下，不会单纯因为这些微小的变更合并起来，就要求进行生物等效性研究，这些微小的变更本身不需要生物等效性研究。

3.    Q: For SUPAC-IR changes which require an in-vivo bioequivalence test, is this requirement also intended for AA drugs which were exempt from bioequivalence testing when originally approved?

3.问题：对于需要进行体内生物等效性研究的SUPAC-IR变更，这一要求是否也适用于最初批准时豁免生物等效性试验的AA药物？

A: The Center did not intend for SUPAC-IR to impose additional bioequivalence requirements for AA drugs beyond those in an original application. (AA drugs are those identified in the Orange Book as not presenting bioequivalence problems.) Therefore, if bioequivalence testing was not required originally, it will not be required under SUPAC-IR for AA drugs.

回答：除了最初申报中要求的以外，CDER没有在SUPAC-IR中对AA药物强加其他生物等效性要求。（AA药物是指“橘皮书”中确定的无生物等效性问题的药物）。因此如果最初不需要进行生物等效性研究，则根据SUPAC-IR，AA药物就不需要进行生物等效性研究。

4.    Q: Would an in vivo bioequivalence study be needed for an AAA@ or non-bioequivalence problem DESI drug even if it one would be needed according to SUPAC?

4. 问题：对于AA药物或无生物等效性问题的DESI（药效研究实施方案）药物，是否需要按照SUPAC 进行体内生物等效性研究？

A: No, since that would conflict with the agency's current bioequivalence policy.

回答：不需要，因为这与FDA 现行的生物等效性政策冲突。

5.    Q: When a bio study is required under SUPAC-IR, to what product should a generic product be compared - the Reference Listed Drug or the generic product approved prior to the SUPAC change.

5. 问题：如果按照SUPAC-IR需要生物等效性研究，仿制药应当与什么产品进行比较——参比制剂还是SUPAC 变更前批准的仿制药。

A: An innovator product should be compared to itself. A generic should be compared to the reference listed drug for that drug product.

回答：创新药应当与其自身进行比较。仿制药应当与该药品的参比制剂比较。

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