Adriana Spera The clinical research center of the University Foundation Gabriele d

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Adriana Spera The clinical research center of the University Foundation Gabriele d'Annunzio of Chieti wrong testing bioequivalence omeprazole product from seven different pharmaceutical companies and the Agency for the Italian Drug Agency (AIFA) revocation with immediate effect the permissions for the 'placing on commerciodi beyond diet 14 prepared to fight ulcer and gastritis.
The decision was published in the Official Gazette of 17 December 2009 and relates to the packs of 14 tablets of omeprazole rigid 10 and 20 mg produced beyond diet by: Angenerico (Gruppo Angelini), Ranbaxy, Fidia, Rk, lpd (Industrial Pharmaceutical Development), Sofar and Blue Fish Pharma.
The AIFA explains that these products can not be kept on the market as a result of specific inspections on clinical bioequivalence study of omeprazole Crc - 022-06 and Crc - 029-06, conducted 6 to 10 April 2009 at the center of Clinical Research Foundation University of Chieti in the Center for the Study of aging (CE.SI) "were highlighted critical deviations from the principles and guidelines of good clinical practice standards beyond diet laid down by Community beyond diet law."
So "bioequivalence studies submitted in support of applications for marketing authorization (Marketing Authorisation, ed) for the medicinal product concerned, have not been conducted - writes the AIFA - in accordance with the applicable rules and without respecting the principles and the guidelines of the Rules of good clinical practice (GCP) and that the results are not reliable. " Just "considered that due to these deviations criticism the Italian Drug Agency considers unreliable results of clinical trials bioequivalence omeprazole" and after the allegations of ritual to manufacturers and having heard about the matter, was Agency banned the sale of 14 preparations.
Against the decision taken by AIFA - we read in the order published in the Official - pharmaceutical companies concerned may be appealed before the same agency, to be submitted within thirty days from the notification of the same measure. There is now to be seen whether there will be legal consequences on the unfortunate affair. Tweet SEARCH Related stories
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