samedan logo
 
 
spacer
home > pmps > spring 2003 > stability issues and outsourcing solutions
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Stability Issues and Outsourcing Solutions

Stability studies are an essential element of the drug development process. The purpose of a stability study is to provide evidence on how the quality of a drug substance or drug product varies over time when subjected to a variety of environmental factors, such as temperature, humidity and light. This information can then be used to ascertain a re-test period for the drug substance or determine the shelf life of a product. Additionally, specific recommendations can be made with regard to appropriate storage conditions and optimum packaging systems.

Depending on the scale of the study - the number of product lots involved, dosage strength, storage conditions and duration - a typical stability study will place a heavy burden on resources and personnel. It will also generate a huge amount of data that will need to be processed and interpreted.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Elma Brennan, Head of the Pharmaceutical Laboratory at RSSL Pharma

Elma Brennan joined RSSL Pharma in 1995 and has helped establish the company as a leading supplier of contract analytical solutions to the pharmaceutical industry. She is now Head of the Pharmaceutical Laboratory at RSSL Pharma.

spacer
Elma Brennan
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Myonex Opens New Global Headquarters

Myonex, a leading global clinical trial supply company, marked the opening of its new global headquarters and US operational facility with a ribbon-cutting ceremony on the company’s 14-acre campus.
More info >>

White Papers

Overcoming research challenges with Adaptive Trials

PCI Pharma Services

There has been cause for concern within the pharmaceutical industry over the last five years, regarding increasing research and development costs, combined with a fall in the number of new drugs brought to market. In an attempt to overcome this issue there has been a significant rise in the use of adaptive clinical trial designs, whilst saving time and money as well as facilitating more effective decision making. One of the biggest challenges that pharmaceutical companies have experienced has been delivering compliant clinical trials supplies across diverse patient populations in the relatively short timeframes that adaptive trial designs require, remaining focused on ensuring that patient compliance and product quality is in no way compromised. This demand has led to the launch of fast response services that support Research and Development in responding to changing dosing regimens mid-trial.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement