ANDA MR 开发模板实例1.pdf

dxy论坛新药版首发，zz_76翻译 Example QbD MR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development 实例QbD MR 片剂 模块3 质量3.2.P.2 药物开发 Quality by Design for ANDAs: ANDAs 的质量源于设计： An Example for Modified Release Dosage Forms 缓释制剂的实例 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). 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) 。 The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their development process and to promote discussion on how OGD would use this information in review. 该实例的目的是说明ANDA 申请人在其开发过程中实施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 the 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@ 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@ 。 2011 年11 月