
Monoclonal Antibodies for Malaria Prevention : Preferred Product Characteristics and Clinical Development Considerations.
Title:
Monoclonal Antibodies for Malaria Prevention : Preferred Product Characteristics and Clinical Development Considerations.
ISBN:
9789240070981
Edition:
1st ed.
Physical Description:
1 online resource (36 pages)
Contents:
Intro -- Acknowledgements -- List of abbreviations -- Overview -- Terminology -- 1. Background and purpose -- 2. WHO strategic goals for malaria mAbs -- 2.1 Priority use case scenario: reduction of morbidity and mortality in children -- 2.2 Other use case scenarios for future consideration -- 2.3 Use of mAbs with other malaria control interventions -- 3. State of the art -- 4. Clinical research and development considerations -- 4.1 End-points, case definitions and analytical strategies in late-stage clinical development -- 4.2 Trial design considerations -- 4.3 Safety considerations -- 4.4 Modelling and simulation to inform target mAb product characteristics -- 5. Production and manufacturing -- 6. WHO prequalification -- 7. PPCs for mAbs to reduce malaria morbidity and mortality in children -- References -- Annex 1. Clinical development data standardization templates.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
Genre:
Electronic Access:
Click to View