Pharmaceutical regulators are becoming more cautious about approving innovative medicines for consumers safety The US Food and Drug Administration FDA has established many regulations that govern the development testing and production processes of dr..
The future of pharma regulations is challenging with diverse and complex regulations globally It will be challenging for industry to adapt to regulated and semiregulated markets alike while attempting to develop a harmonised strategy with evergrowing..
Drug development is a complex time consuming and expensive process involving numerous stakeholders activities and regulatory authorities Broadly it can be classified in six steps starting from identification of lead molecule till submission of report..
All protein biotherapeutics are potentially immunogenic and hence could elicit immunogenicity response These responses could be of different types such as binding antibodies or neutralising antibodies Immunogenicity of protein biotherapeutics is a ma..
Todays pharmaceutical environment has become increasingly complex with more specialty products like biologics injectable and clinical trial drugs being shipped than ever The industry standard for commercial packaging is 120 hours which is no longer a..
In this interview Peter Soelkner of Vetter discusses drug delivery trends for biologics and in particular prefilled syringes He offers insight into the advantages and challenges of this system for biologics important issues to consider upfront and ta..