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Dosage form Design: Dissolution, Bioequivalence and if biowaiver can be applied
6 December 2016
Dosage form Design: Dissolution, Bioequivalence and if biowaiver can be applied

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.
For example, concerning modified release products, two different guidelines have been recently published by EMA with different scopes. One is covering the quality side (Guideline on quality of oral modified release products, EMA/CHMP/QWP/428693/2013published in March 2014)
Whilst the other is covering pharmacokinetics and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) published November 2014:

 

Masterclass LEADER

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Muhaned Al-Hindawi

Managing Director & Principal Consultant , Ontarget pharma Consultancy

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. 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 profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

Ontarget pharma Consultancy

Ontarget pharma Consultancy is a leading pharmaceutical consulting company based in London, UK. The aim is to provide a high standard of pharmaceutical consultancy covering the areas of regulatory affairs and technical requirements governed by the current Directives and guidance for marketing authorisation of medicinal products in UK and rest of EU.
Detail of the services provided can be seen by browsing the company’s website www.ontargetpharma.com
 

Masterclass agenda

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8:30

Registration & Coffee

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9:00

Critical review of guidance on the quality and bioequivalence of immediate release preparations.

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

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11:30

Morning Coffee

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11:50

Critical review of guidance on the quality and bioequivalence of prolonged release products.

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

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12:30

Critical review of guidance on the quality and bioequivalence of gastro-resistant products

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

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13:00

Networking Lunch

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14:00

Two case studies in which the competent authority in EU had intervened requesting further information to justify the biowaiver request made:

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

-Effect of excipient on the bioavailability of the API from aqueous oral solution and biowaiver criteria
-Composition proportionality & dissolution similarity of multiple strengths formulations of oral solid dosage forms
 

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15:00

Afternoon Tea

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15:20

Panel Discussion

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

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16:00

Closing remarks

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy

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16:30

End of workshop

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