Evaluating Current Practices in Shelf Life Estimation
نویسندگان
چکیده
منابع مشابه
Drug Shelf-life Estimation
The shelf-life of a drug product is the time that the average drug characteristic (e.g., potency) remains within an approved specification after manufacture. The United States Food and Drug Administration (FDA) requires indication for every drug product of a shelf-life on the immediate container label. Since the true shelf-life of a drug product is typically unknown, it has to be estimated base...
متن کاملThe Estimation of Drug Shelf-life
In the pharmaceutical industry, a stability study is usually conducted to establish the drug expiration dating period(or shelf-life) of a drug product. The method suggested in the current FDA guidelines does not consider the situation when there is a batch-to-batch variation. Chow and Shao (1991) proposed a model which can take into account the batch-to-batch variation results. In this paper, a...
متن کاملLife Settlement Funds: Current Valuation Practices
We analyze the prevailing valuation practices in the life settlement industry based on a sample of 11 funds that cover a large portion of the current market. The most striking result is that a majority of asset managers seem to substantially overvalue their portfolios relative to the prices of comparable transactions that have recently been closed. Drawing on market-consistent estimates with re...
متن کاملEvaluating current policy for detecting mosaicism in amniotic fluid cultures: implications for current cell counting practices.
Chromosomal mosaicism is one of the most vexing problems for clinical cytogenetic laboratories and personnel time used for analysis at the microscope is one of the principle costs in cytogenetic laboratories. We use data collected from 26 cytogenetic laboratories to evaluate whether the American College of Medical Genetics guidelines for minimum number of cells to count to exclude mosaicism in ...
متن کاملFinancial Regulation in the United Kingdom:Historical Foundations and Current Practices
Financial markets have been developed rapidly in recent years. New and sophisticated financial tools have been the cause of these developments which need new controlling systems to prevent crisis. Most of industrial economies have reformed regulatory structure of their financial systems. This paper reviews the regulatory developments of UK in this regard and offers new regulations and ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: AAPS PharmSciTech
سال: 2017
ISSN: 1530-9932
DOI: 10.1208/s12249-017-0880-4