Risk management of biologicals: a regulatory and clinical perspective

Keyphrases

• Regulatory Aspects 100%
• Adverse Drug Events 100%
• Risk Management 100%
• Clinical Perspective 100%
• Rituximab 57%
• Invasive Aspergillosis 42%
• Thrombocytopenia 42%
• Small Molecule Drugs 42%
• Clinical Trials 28%
• Risk Factors 28%
• Regulatory Actions 28%
• Clinical Risk Management 28%
• Event Profile 28%
• Postmarketing 28%
• Safety Profile 28%
• Safety-related Regulatory Action 28%
• Risk Profile 14%
• Oncology 14%
• Healthcare Professionals 14%
• Cumulative Dose 14%
• Drug Use 14%
• Clinical Practice 14%
• High Risk 14%
• Immunogenicity 14%
• Treatment Options 14%
• Autoimmune 14%
• Candida Infection 14%
• Active Pharmacovigilance 14%
• Hematological Malignancies 14%
• Regulatory Activity 14%
• Fungal Infection 14%
• Pharmacological Activities 14%
• Safety Data 14%
• Serious Condition 14%
• Pharmacovigilance 14%
• Chemically Synthesized 14%
• Therapeutic Class 14%
• Low Platelet Count 14%
• Clinical Laboratory Data 14%
• Regulatory Risk 14%
• Thrombocyte Count 14%
• Frequent Monitoring 14%
• Drug Class 14%
• Risk Identification 14%
• Safe Use 14%
• Clinical Setting 14%
• Biological Agents 14%
• Pharmacoepidemiology 14%
• Different Characteristics 14%

Pharmacology, Toxicology and Pharmaceutical Science

• Biological Product 100%
• Adverse Drug Reaction 46%
• Rituximab 26%
• Invasive Aspergillosis 20%
• Thrombocytopenia 20%
• Clinical Trial 13%
• Pharmacovigilance 13%
• Immunogenicity 6%
• Pharmacological Activity 6%
• Infection 6%
• Hematologic Malignancy 6%
• Mycosis 6%
• Candidiasis 6%