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Drug Development for Rare Diseases
ISBN-13:
9781000820225
Veröffentl:
2023
Seiten:
232
Autor:
Bo Yang
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
0 - No protection
Sprache:
Englisch
Beschreibung:
A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans. This diverse and complex disease area poses challenges for patients, caregivers, regulators, drug developers and other stakeholders.
1. Introduction to Rare Disease Therapy Development 2. Challenges and Opportunities in Rare Disease Drug 3. Developing Drugs for Rare Diseases: Regulatory Strategies 4. Clinical Trial Design and Analysis Considerations for Rare Diseases 5. Use of Real-World Evidence to Support Drug Development 6. Clinical Development of Pediatric Program within Rare Diseases 7. Use of Modeling and Simulation in Support of Drug Development for Rare Diseases 8. Case Studies of Rare Disease Drug Development
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