Module 3 2019
Target Product Profile
The clinical condition
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• Acute, chronic, severity, duration of treatment
The “user” (patient)
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• Age, health, mental awareness, cultural factors
The drug substance
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Dose and dosage regimen
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Pharmaceutical properties
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Biopharmaceutical properties
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• Drug /Drug Product Manufacture considerations
Route of administration
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• Facilities, equipment, expertise, sourcing policy
The Organisation for Professionals in Regulatory Affairs
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