【分享】ANDA IR片剂开发模板-(IR片剂实例的第一部分：处方研究)

朱丹

ANDA IR片剂开发模板-(IR片剂实例的第一部分：处方研究)

Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms
ANDAs的质量源于设计：速释制剂的实例
Introduction to the Example 实例简介
This is an example pharmaceutical development report illustrating how ANDA applicants can
move toward implementation of Quality by Design (QbD). The purpose of the example is to
illustrate the types of pharmaceutical development studies ANDA applicants may use as they
implement QbD in their generic product development and to promote discussion on how OGD
would use this information in review.
这是一个有关药物开发报告的实例，用以说明ANDA申请人如何实施质量源于设计(QbD)。
该实例的目的是说明ANDA申请人在其仿制药开发过程中实施QbD时，可使用的药物开发研
究的类型，同时促进探讨OGD在审评中如何使用该信息。
Although we have tried to make this example as realistic as possible, the development of a real
product may differ from this example. The example is for illustrative purposes and, depending on
applicants’ experience and knowledge, the degree of experimentation for a particular product may
vary. The impact of experience and knowledge should be thoroughly explained in the submission.
The risk assessment process is one avenue for this explanation. At many places in this example,
alternative pharmaceutical development approaches would also be appropriate.
虽然我们已试图让实例尽可能切合实际，但真实产品的开发可能与该实例不同。该实例是用
于说明的目的，并取决于申请人的经验和知识，个别产品的实验程度可能会有所不同。在提
交时应充分说明经验和知识的作用。风险评估过程是该解释的一个途径。该实例的许多地方，
也可适用其他药物开发方法。
Notes to the reader are included in italics throughout the text. Questions and comments may be

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albertchen

wangrong1100200 发表于 2014-11-4 20:19
还有一个MR的。

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