Statistical issues in first-in-human studies on BIA 10-2474: Neglected comparison of protocol against practice

Keyphrases

• Statistical Issues 100%
• BIA 10-2474 100%
• First-in-human 100%
• United Kingdom 50%
• Healthy Volunteers 50%
• Pharmacokinetics 50%
• Working Party 50%
• Dose Determination 50%
• Multiple Ascending Dose 50%
• Cytokine Release Storm 50%
• Stopping Rule 50%
• Safety Committee 50%
• Single Ascending Dose 50%
• Royal Statistical Society 50%
• Dosing Interval 50%

Biochemistry, Genetics and Molecular Biology

• Human Study 100%
• Cytokine Release 50%
• Normal Human 50%
• Pharmacokinetics 50%

Pharmacology, Toxicology and Pharmaceutical Science

• Human Study 100%
• Normal Human 50%
• Cytokine 50%
• Pharmacokinetics 50%