FDA CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data

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GUIDANCE FOR INDUSTRY STATISTICAL EVALUATION OF STABILITY DATA 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 appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 1. INTRODUCTION 1.1 Objectives of the Guidance This guidance is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled, “Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)” (hereafter referred to as the parent guidance) to propose a retest period or shelf life in a registration application. This guidance describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a veterinary medicinal product that extends beyond the period covered by available data from the stability study under the long-

term storage condition (hereafter referred to as long-term data). Application of this guidance is entirely optional and it is up to the applicant to decide whether or not to use statistical analysis to support the claimed retest period/shelf-life. 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 cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1.2 Background The guidance on the evaluation and statistical analysis of stability data provided in the parent guidance is brief in nature and limited in scope. The parent guidance states that regression analysis is an appropriate approach to analyzing quantitative stability data for retest period or shelf life estimation and recommends that a statistical test for batch poolability be performed using a level of significance of 0.25. However, the parent guidance includes few details and does not cover situations where multiple factors are involved in a full- or reduced-design study. This guidance is an expansion of the guidance presented in the Evaluation sections of the parent guidance. 1.3 Scope of the Guidance This guidance addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated veterinary medicinal products. The guidance provides recommendations on establishing retest periods and shelf 4

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