{"product_id":"shelf-life-designing-and-analysing-stability-trials-von-andreas-kiermeier","title":"Shelf-life: Designing and Analysing Stability Trials","description":"\u003cp\u003eAll pharmaceutical products are required by law to  display the shelf-life on the packaging, which  indicates the period during which the consumer can  expect the product to be safe and effective.   Standard methods for determining the label shelf- life from stability data are limited to linear  models. Where a number of batches are used to  determine a label shelf-life, the current regulatory  method (unintentionally) penalizes good statistical  design. In this work it is shown that the current  approaches may not provide the consumer with the  desired level of confidence that the product is safe  and effective. Consequently, a new definition for  the label shelf-life is proposed, such that the  consumer can be confident that a certain percentage  of the product will meet the specification by the  expiry date. Several methods for obtaining such a  label shelf-life under linear model and generalized  linear model assumptions are proposed and evaluated  using simulation studies. The definition is extended  so that a single shelf-life can be obtained from  multiple batches.\u003c\/p\u003e\u003cdiv class=\"aw-variant-hidden-subtitle-div\" id=\"aw-variant-subtitle-9783838352626\"\u003e\u003ch3\u003eStatistical Approaches\u003c\/h3\u003e\u003c\/div\u003e","brand":"Autorenwelt Shop","offers":[{"title":"Softcover - 9783838352626","offer_id":39499070472285,"sku":"9783838352626","price":59.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0940\/0622\/files\/526ac5a8-0521-4260-9cc8-f347558a71c9.jpg?v=1757911484","url":"https:\/\/shop.autorenwelt.de\/products\/shelf-life-designing-and-analysing-stability-trials-von-andreas-kiermeier","provider":"Autorenwelt Shop","version":"1.0","type":"link"}