FDA QbD实例 速释片 Example QbD for IR Tablet(中英文对照).pdf

Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development IR 片剂QbD 实例模块3 质量3.2.P.2 药物开发 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 sent to GenericDrugs@fda.hhs.gov 整篇文章的斜体内容为致读者的内容。如有任何问题和意见，请发送至 GenericDrugs@fda.hhs.gov 。 2012 年4 月 1 Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development IR 片剂QbD 实例模块3 质量3.2.P.2 药物开发 Pharm