Hear the latest insights from Johnson & Johnson, GSK, Merck Sharp & Dohme, Grunenthal, Lek Pharmaceuticals, d.d., UCB Pharma and Shire Pharmaceuticals
Hear from Infarmed and the FDA on how to practically comply with the regulatory requirements for modified release dosage forms
Hear insights from industry on tamper resistant MR formulations, the physiological based modelling approach and designing robust hydrophilic matrix tablets
Getting modified release drugs onto the market extends drug lifecycles and oral modified release pharmaceutical products account for one third of the total speciality pharma market.
However, because of their complexity, oral modified-release dosage forms are challenging to develop and manufacture and it is now more important than ever to examine the methods and technologies available to get your product onto the market, fast.
Modified Release in Oral Drug Delivery will provide you with the insights into the latest technologies and methods that industry leaders are deploying. Moreover, the conference will offer the opportunity to examine the latest EMA guidance, the timeline for its release and its implications for industry.
The guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms has now been released and the EMA will be taking comments until 15 September 2013. Click here to view the draft guideline.
The primary purpose of the guideline is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release and transdermal dosage forms in man. Additionally, the guideline sets out general principles for designing, conducting and evaluating such studies.
Modified Release in Oral Drug Delivery will offer the opportunity to examine the latest EMA guidance, the timeline for its release and its implications for industry.