Acquired expertise in HV and/or patients

1. Effect of gastric pH on drug absorption: pump inhibitors administration allows increasing gastric juice pH that can be continuously recorded by nasal-gastric probes while the rate and extent of the systemic absorption of a test drug is concurrently measured.

2. Gastrolesivity evaluation: NSAIDs alone or in combination administered at high dosages according to multiple regimens induce gastric damages (erosions, submucosal hemorrhages, ulcers) that can be easily monitored and scored by gastric endoscopy, (1).

3. Small intestine damages: the most recent Video Capsule Endoscopy with the PillCam™, is a valuable tool to investigate, throughout the whole gastro intestinal tract but particularly in the non endoscopically accessible small intestine, treatment related events.

4. Pharmaco-scintigraphy: is a technique used to evaluate the  in vivo performance of new oral delivery systems, i.e. capsules, tablets, pellets, enemas. When these data are compared with the PK of the drug it is possible to relate the drug absorption to the formulation fate in the GI tract (location, transit, disintegration, persistence). Complex forms, like enteric-coated tablets, can be labelled by the addition of a non-radioactive tracer as 152Sm2O3 followed by neutron activation of the final product, (2, 3).


1) Fiorucci S, Santucci L, Gresele P, Faccino RM, Del Soldato P, Morelli A. Gastrointestinal safety of NO-aspirin (NCX-4016) in healthy human volunteers: a proof of concept endoscopic study. Gastroenterology. 2003 Mar;124(3):600-7.

2) Brunner M, Assandri R, Kletter K, Tschurlovits M, Corrado ME, Villa R, Eichler HG, Muller M. "Gastrointestinal transit and 5-ASA release from a new mesalazine extended-release formulation". Aliment Pharmacol Ther. (2003). 17, 395-402.

3) Brunner M, Ziegler S, Di Stefano AF, Dehghanyar P, Kletter K, Tschurlovits M, Villa R, Bozzella R, Celasco G, Moro L, Rusca A, Dudczak R, Muller M. "Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation". Br J Clin Pharmacol. (2005) ,61, 31-38.

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