Additional Notes This note for guidance concerns the application of Part 4, section E of the Annex to Directive 75/318/EEC as amended and Article 4,2 point 8 of Directive 65/65/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It defines when bioavailability or bioequivalence studies are necessary for immediate release products with a systemic effe...

In the first-ever demonstration of FinFET technology suitable for 10-nm CMOS manufacturing – pushing device scaling two nodes beyond the current leading-edge volume production technology – Samsung and others will jointly showcase a platform technology for low-power and high-performance applications. It offers the tightest contacted poly pitch (64 nm) and metallization pitch (48 nm) ever reporte...

Nine horses received 20 mg/kg of intravenous (LEVIV ); 30 mg/kg of intragastric, crushed immediate release (LEVCIR ); and 30 mg/kg of intragastric, crushed extended release (LEVCER ) levetiracetam, in a three-way randomized crossover design. Crushed tablets were dissolved in water and administered by nasogastric tube. Serum samples were collected over 48 hr, and levetiracetam concentrations wer...

The aim of the present work was to develop immediate release dosage form of the solid dispersion of glimperide (GLIM) for potential enhancement in the bioavailability. The solid dispersions of GLIM were prepared with PEG6000, PVP K30 and Poloxamer 188, in 1:1, 1:3 and 1:5 %w/w ratio by using solvent wetting and solvent melt method. The in vitro dissolution parameters (%DE10min, %DE30min, %DE60m...

The aim of this article is to provide a short review of the most relevant pharmacological and clinical data on pramipexole extended release (ER) as well as to address the clinical utility and potential advantages of a once-daily formulation especially in the treatment of early Parkinson's disease (PD). Pramipexole is widely established as a symptomatic treatment in early as well as advanced PD....

Controlled release delivery is available for many routes of administration and offers many advantages (as microparticles and nanoparticles) over immediate release delivery. These advantages include reduced dosing frequency, better therapeutic control, fewer side effects, and, consequently, these dosage forms are well accepted by patients. Advances in polymer material science, particle engineeri...