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

Descrição não disponível.
1. Enabling customer-centric and sustainable drug delivery-formulation and device lifecycle management of biotherapeutics
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
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?Biological medicine; Biopharmaceutical; Biotherapeutics; Drug delivery; Handheld syringe; Healthcare expenditure; Infusion set; Lifecycle management; MAbs; Monoclonal antibodies; Patient-centric product; Prefilled syringe; Subcutaneous formulations; Subcutaneous injection