Pharmaceutical Regulatory Affairs: Open Access

The present impacts of the Biopharmaceutics Classification System (BCS) and Biopharmaceutics Drug Disposition Classification System (BDDCS) on pertinent scientific advancements are discussed. The detailed study of the dissolution of poorly absorbed BCS class II drugs in nutritive liquids (such milk and peanut oil) and biorelevant media for the precise prediction of the rate and degree of oral absorption is one of the key BCS accomplishments.

Now, it is possible to test brain models, animate the cerebral cortex and cure mental illnesses using constrained electric fields. In terms of interpretation, the plasticity of the brain was investigated using a mouse model of intracortical microstimulation employing acoustoelectric transduction of ultrasonic signals. Deep cerebrum feeling (DBS) treatment, which is similar to neuromodulation, has been shown to be effective in treating drug-safe epilepsy in clinical studies. Because electrical feeling through intracranial terminals can affect electrical transmission inside the brain, transcranial electrical stimulation (tES), which is delivered safely through the scalp, can be used to activate these fields. The advantages of tES include its affordability, versatility and potential at-home applications, which address the rise in human preliminary tests.

Biopharmaceuticals production is based on a GMP system of quality control used for the regulatory scope. Relvant for this role the analytical procedure, specificity and sensibility of the methods to test raw materials but also the final products before commercialization. Aim of this work is to verify the role played by nanolipids on Raman Spettroscopy encapsulating active principle or other substantia unsing different procedure: 1) Destructive and 2) Non destructive technique. This is relevant because regualtory agency authorized ( EMA) for cGMP rules the use also of non destructive methods like RAMAN spettroscopy in various stage of manifacturing drugs ( for raw material and final product).