A quantitative prediction of human pharmacokinetic (PK) profiles has become an increasing
demand for the reduction of the clinical failure of drug formulations. The existing in vitro and …

The gastrointestinal (GI) tract is one of the most popular and used routes of drug product
administration due to the convenience for better patient compliance and reduced costs to the …

Dissolution profiles comparison is an important element in order to support biowaivers, scale-
up and post approval changes and site transfers. Highly variable dissolution can possess …

O acesso a medicamentos pode ser facilitado por programas globais de desenvolvimento
farmacêutico, mas há necessidade de que as agencias regulatórias e as indústrias …

No Brasil, ao longo dos últimos 40 anos, o Governo Federal tem buscado incentivar o
desenvolvimento da indústria nacional, especialmente a de fármacos e medicamentos. Em …

Developing a drug product with multiple strengths has several advantages: it helps meet
individual patients' needs, offers an advantage for drugs requiring titration, avoids splitting …

November 30, 2018–EMA has published revised guidelines on the tests and studies needed
to support marketing authorisation applications for certain haemophilia medicines. The …

The article offers guidelines by the European Medicines Agency (EMA), to support marketing
authorization applications for certain haemophilia medicines for factor IX deficiency. It …

The article explore the concept of biowaiver a magic wand to wave away the requirements
for expensive in vivo testing. Topics discussed include biowaiver apply to formulations such …

Cilj istraživanja Cilj ovog specijalističkog rada je pregledno opisati regulatorne smjernice
Europske agencije za lijekove (EMA) za ispitivanje bioraspoloživosti i provjere …