Target Product Profiles for Animal Plasma-Derived Antivenoms : Antivenoms for Treatment of Snakebite Envenoming in Sub-Saharan Africa.
| Format: | eBook |
|---|---|
| Language: | English |
| Published: |
Geneva :
World Health Organization,
2023.
|
| Edition: | 1st ed. |
| Subjects: | |
| Online Access: | Click to View |
Table of Contents:
- 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.