CRED Bioequivalence and Biowaivers Practical Workshop ~ Slides

CRED Bioequivalence and Biowaivers Practical Workshop 19 April 2018, TOPRA, 6 th Floor, 3 Harbour Exchange, South Quay, London, UK

Presenter: Dr. Muhaned Al-Hindawi

Time

Presentation

9.00

Registration

Welcome from TOPRA

9.30

Introduction •

9.40

Overview of the day

Immediate release products - Generic • Definition & Criteria • Quality & Pharmaceutical equivalence • In vitro dissolution • Bioequivalence • Biowaiver

9.50

11.50

Tea/coffee break

Prolonged release products - Generic • Definition & Types • Quality & Pharmaceutical development • In vitro Dissolution & Setting Specification • Bioequivalence • Biowaiver & Bracketing

12.10

13.00

Lunch

Gastro-resistant products - Generic • Definition • Quality • In vitro Dissolution • Bioequivalence • Biowaiver

14.00

Case study of dosage form design and bioequivalence of multiple strengths dosage form

14.30

15.20

Tea/coffee break

15.40

Case study of effect of excipient on the bioavailability of oral solution

16.10

Panel discussion

16.40

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