Target Product Profiles for Animal Plasma-Derived Antivenoms : Antivenoms for Treatment of Snakebite Envenoming in Sub-Saharan Africa.
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Cover -- Title -- Copyright -- Contents -- Acknowledgements -- Glossary of key terms and abbreviations -- Executive summary -- Introduction -- Unmet medical need/problem -- Rationale -- Use-case scenarios -- Scope of TPPs -- Indications and contraindications -- Manufacturing considerations -- Active pharmaceutical ingredient -- Finished product form -- Protein and immunoglobulin content -- Preclinical efficacy studies -- Clinical considerations -- Frequency and route of administration -- Stability, storage, presentation and packaging -- Affordability and access -- Supportive/adjunctive therapy -- Training and education -- Animal plasma-derived antivenom TPP list -- Target product profiles for sub-Saharan Africa -- Common characteristics of TPPs -- All sub-Saharan African, animal plasma-derived antivenoms -- Scope -- Manufacturing Consideraton -- Performance -- Operational Characteristics -- Specific characteristics of TPPs -- Broad-spectrum pan-African polyvalent antivenoms -- Scope -- Manufacturing Considerations -- Performance -- Sub-Saharan African monovalent antivenoms -- Scope -- Manufacturing Considerations -- Performance -- Pan-African polyvalent antivenoms for neurotoxic envenoming -- Scope -- Manufacturing Considerations -- Performance -- Pan-African polyvalent antivenoms for non-neurotoxic envenoming -- Scope -- Manufaturing Considerations -- Performance -- Clinical effectiveness of antivenoms for sub‑Saharan Africa -- Clinical Outcomes -- Death -- Restoration of blood coagulability -- Neurotoxicity -- Amputation and other functional loss -- Tissue necrosis -- Rhabdomyolysis -- Cost-effectiveness of antivenoms for sub-Saharan Africa -- References -- Bibliography.
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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2023. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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