Formulation and Device Lifecycle Management of Biotherapeutics
Formulation and Device Lifecycle Management of Biotherapeutics
A Guidance for Researchers and Drug Developers
Bittner, Beate; Schmidt, Johannes
Elsevier Science Publishing Co Inc
01/2022
228
Mole
Inglês
9780128237410
15 a 20 dias
450
2. Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies-pharmacokinetic-based bridging approach
3. Clinical development of automated subcutaneous injection devices-established pathways and novel concepts
4. Enabling a flexible care setting in oncology-how to realize home- and self-administration of biotherapeutics in cancer care
5. Formulation and device lifecycle management of biotherapeutics-leveraging synergies across therapeutic areas
6. Formulation and device lifecycle management of biotherapeutics-decision architecture
7. Summary and outlook
2. Clinical development of subcutaneous dosing alternatives to established intravenous formulations for monoclonal antibodies-pharmacokinetic-based bridging approach
3. Clinical development of automated subcutaneous injection devices-established pathways and novel concepts
4. Enabling a flexible care setting in oncology-how to realize home- and self-administration of biotherapeutics in cancer care
5. Formulation and device lifecycle management of biotherapeutics-leveraging synergies across therapeutic areas
6. Formulation and device lifecycle management of biotherapeutics-decision architecture
7. Summary and outlook