Quality-by-Design of nano-pharmaceuticals - a state of the art - Archive ouverte HAL
Article Dans Une Revue Nanomedicine: Nanotechnology, Biology and Medicine Année : 2017

Quality-by-Design of nano-pharmaceuticals - a state of the art

Résumé

Pharmaceutical Quality-by-Design is a risk-based approach of drug development relying on the understanding of both the product and the process. This state of the art analyzes 24 studies published during the last ten years. A risk modeling of the nanomaterial formulation and manufacturing is firstly presented. After a brief history of the QbD approach, its basic components are recalled in a second part. The most critical material attributes, process parameters, quality variables and measurement technologies are reviewed. Specific deficiencies are also emphasized such as the absence of prior risk assessment, production scale-up, process analytical technology and control strategy. Finally, perspectives and development priorities are drawn to improve the implementation of this integrative approach of quality and safety in nanomedicine.

Dates et versions

hal-01544635 , version 1 (21-06-2017)

Identifiants

Citer

Thierry Thierry Bastogne. Quality-by-Design of nano-pharmaceuticals - a state of the art. Nanomedicine: Nanotechnology, Biology and Medicine, 2017, 13 (7), pp.2151-2157. ⟨10.1016/j.nano.2017.05.014⟩. ⟨hal-01544635⟩
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