首页   按字顺浏览 期刊浏览 卷期浏览 SOME CONSIDERATIONS ABOUT STABILITY STUDY DESIGN
SOME CONSIDERATIONS ABOUT STABILITY STUDY DESIGN

 

作者: Paolo Repeto,  

 

期刊: Journal of Biopharmaceutical Statistics  (Taylor Available online 2000)
卷期: Volume 10, issue 1  

页码: 73-82

 

ISSN:1054-3406

 

年代: 2000

 

DOI:10.1081/BIP-100101014

 

出版商: Taylor & Francis Group

 

关键词: Consumer loss;Producer gain

 

数据来源: Taylor

 

摘要:

The aim of a stability study is to check whether or not a drug maintains its initial properties (over a given range) in a period of time. There are many parameters considered in a stability study, but in this paper only the active content will be considered. Evaluation of this parameter is performed by measuring the content of the active ingredient in the drug at different times and on expiration to see if it is within specification [1]. The problem also involves estimating whether the drug will perform satisfactorily and maintain its initial properties in the future. In this paper, we provide a criterion for the evaluation of experimental design used in a stability study for predicting the content of an active ingredient in a drug, starting from the confidence limit calculated following International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) recommendations. The point of view adopted is akin to hypothesis testing. The main question is this: “If the drug fulfills the requirements at a given time in the future, what is the probability that the data collected for that drug will show its suitability?” For this purpose, two concepts are used—producer gainandconsumer loss—which are defined as follows: producer gain is the advantage (for the producer) of recognizing a drug as “good” (provided it is good and within specification); consumer loss is the loss (for the consumer) when the drug is no longer good, but the data collected indicate that it is good. The aim of the experimental design in this study is to increase the probability of producer gain and maximize it on the basis of a given consumer loss.

 

点击下载:  PDF (113KB)



返 回