美国FDA 指导原则 天花(天花病毒)感染开发治疗或预防药物工业指南 英文原版.pdfVIP

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) November 2019 Clinical/Antimicrobial Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) November 2019 Clinical/Antimicrobial TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 2 III. DEVELOPMENT PROGRAM 4 A. Multidisciplinary Considerations for Studies in Animal Models Using Orthopoxvirus 4 1. Considerations for Preliminary Assessments of Antiviral Activity in Animal Models 4 2. Key Study Design Considerations for Animal Efficacy Studies to Support Potential NDA Submission Under the Animal Rule 5 3. Selection of an Effective Do