Pharmaceutical development is the phase in the lifecycle of a medicinal product aimed to design the product and the manufacturing process to consistently delivers the intended quality and performance. For inhalation products, compendial texts such as Pharmacopoeias and/or reference guidelines issued by regulatory agencies indicate the characteristics the product must comply with to be used effectively and safely. The characteristics of the product are identified and studied for the first time during the Pharmaceutical Development phase, following a rational design. In this chapter, pharmaceutical development studies for inhalation products are discussed.
Pharmaceutical development studies for inhalation products
COLOMBO, Gaia;
2013
Abstract
Pharmaceutical development is the phase in the lifecycle of a medicinal product aimed to design the product and the manufacturing process to consistently delivers the intended quality and performance. For inhalation products, compendial texts such as Pharmacopoeias and/or reference guidelines issued by regulatory agencies indicate the characteristics the product must comply with to be used effectively and safely. The characteristics of the product are identified and studied for the first time during the Pharmaceutical Development phase, following a rational design. In this chapter, pharmaceutical development studies for inhalation products are discussed.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
