Dosage form design: Link of Dissolution, Bioequivalence and if biowaiver can be applied this December in London
SMi's masterclass on Dosage form design: Link of Dissolution, Bioequivalence and if biowaiver can be applied will be running in London on 6th December 2016.
- (1888PressRelease) November 04, 2016 - In the pharmaceutical industry, formulation scientists are very well educated and experienced according to their merit in the dosage form design to include formulation development, method of analysis, kinetics and stability… etc ensuring compliance with the guideline requirements covering module 3 of the CTD.
However, the clinical side concerning the bioavailability/bioequivalence studies covered in Module 5 of the dossier are usually designed and carried out by a different team of clinical background and experience. The clinical team might not be directly involved in the dosage form design from start and have not gained sufficient experience to positively contribute in the studies covering formulation factors effecting the bioavailability performance of the finished product.
This difference in the background and experience or even orientation between the two different teams within the same pharmaceutical establishment have created a gap in understanding each sides requirements and limitations.
Interestingly this difference and the gap identified in the understanding of the requirements of the quality of the finished product and its design linked to the bioavailability/bioequivalence performance have been relatively demonstrated to a certain extent in the guidelines published and their main scope.
The aim of this workshop is an attempt to fill this gap by linking the quality of the concerned dosage form expressed in terms of dissolution behaviour with its bioavailability/bioequivalence performance required by the guidance.
Two case studies will be presented when the competent authority in EU had intervened requesting further information to justify the biowaiver claim made.
To find out more about the masterclass please visit: https://www.smi-online.co.uk/pharmaceuticals/uk/masterclass/dosage-form-design-link-of-dissolution-to-the-bioequivalence-of-oral-dosage-forms-and-if-biowaiver-can-be-applied
The masterclass will be led by: About your workshop leader:
Muhaned Al-Hindawi, Managing Director & Principal Consultant, Ontarget Pharma Consultancy. Occupied a number of technical posts in the pharmaceutical industry with over 15 years of hand on experience in many areas. This includes new product development, method of analysis construction and process validation. Involved in a number of high profile projects including a joint project between Jordan and EU, upgrading the Jordanian pharmaceutical manufacturing companies to comply with the European standards and levels.
For media enquiries please contact Honey De Gracia on +44 20 7827 6102 or hdegarcia ( @ ) smi-online dot co dot uk
For delegate enquiries contact Fateja Begum +44 (0) 20 7827 6184 or email fbegum ( @ ) smi-online dot co dot uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
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