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Module 5: Acceptability

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Presentation on theme: "Module 5: Acceptability"— Presentation transcript:

1 Toolkit for research and development of paediatric antiretroviral drugs and formulations

2 Module 5: Acceptability

3 Off label or off license paediatric therapy

4 US & EU legislations and guidance

5 Acceptability, adherence, effectiveness and safety

6 Defining acceptability

7 Acceptability, appropriateness, adherence

8 Liquid and solid oral dosage forms

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13 Formulations should have flexible dosage increments and minimal excipients, and should be palatable, safe and easy to administer, and light, humidity and heat stable

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15 Acceptability is a property of the medicinal product

16 It is also defined by the end user

17 Acceptability, adherence, clinical appropriateness

18 From acceptability to adherence

19 Challenges

20 Little guidance, no standardisation

21 What aspects of acceptability should be considered and measured?

22 With which tools should acceptability be measured?

23 Who can provide information on medicine acceptability?

24 Key considerations (1)

25 Key considerations (2)

26 Acknowledgements


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