spacer
home >
PUBLICATIONS

 
 
 
Featured in this issue

The Elephant in the Room

Kurt Mussina at Frenova Renal Research

Systematic and concrete marketing activities are an often overlooked aspect of a successful clinical research business.

 


A Scalable Solution

Susan Najjar at Covance

It is important for smaller enterprises to seek specialised clinical and regulatory support in order to streamline pre- and post-marketing phases.

 

 
Paving the Way

Rik Van Mol at Veeva Systems

In order to drive efficiency and a faster time to market, sponsors, CROs, and pharma companies need to embrace collaboration.

spacer

 

 
News and Press Releases

Nemera joins IPAC-RS as an Associate Member

Nemera is excited to announce that it has become an Associate Member of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Nemera’s decision to join IPAC-RS is part of its commitment to advance science and innovation. Nemera is committed to enhancing better patient outcomes by seeking innovative solutions and contributing actively to discussions about the future of drug delivery devices. Its membership in IPAC-RS will facilitate this important commitment.
More info >>

 
White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement