FDA-溶出度指导原则

Q8 Pharmaceutical Development U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

May 2006

ICH

Q8 Pharmaceutical Development

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/cder/guidance/index.htm

Office of Communication, Training and

Manufacturers Assistance, HFM-40

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, Rockville, MD 20852-1448

/cber/guidelines.htm.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

May 2006

ICH

TABLE OF CONTENTS

I.INTRODUCTION (1, 1.1) (1)

II.PHARMACEUTICAL DEVELOPMENT (2) (2)

ponents of the Drug Product (2.1) (3)

1.Drug Substance (2.1.1) (3)

2.Excipients (2.1.2) (4)

B.Drug Product (2.2) (4)

1.Formulation Development (2.2.1) (4)

2.Overages (2.2.2) (5)

3.Physicochemical and Biological Properties (2.2.3) (5)

C.Manufacturing Process Development (2.3) (6)

D.Container Closure System (2.4) (7)

E.Microbiological Attributes (2.5) (7)

patibility (2.6) (8)

III.GLOSSARY (3) (9)

Guidance for Industry1

Q8 Pharmaceutical Development

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. INTRODUCTION (1, 1.1)2

This guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9 Quality Risk Management) to the development of a product and its manufacturing process. It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle3 of a product. The Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are

1This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2005. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.

2 Arabic numbers reflect the organizational breakdown of the document endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2005.

3 Terms that appear in bold italic type in this guidance are defined in the glossary, section III (3).