Phase Illb studies

Gebel M, Caselitz M, Bowen-Davies PE, Weber S. A multicenter, prospective, open label, randomized, controlled phase Illb study of SH U 508 a (Levovist) for Doppler signal enhancement in the portal vascular system. Ultraschall Med 1998 19(4) 148-56. 

Observational studies A prospective, multicenter, phase Illb study evaluated safety of anidulafungin for the treatment of candidaemia or invasive candidiasis in 216 ICU patients [66 -]. Anidulafungin-related adverse effects were observed in 15.3% of the patients, and the most frequent were erythema (1.9%), hypotension, increased blood alkaline phosphatase, increased aspartate aminotransferase, diarrhoea and atrial fibrillation (each 1.4%). Fom patients (1.9%) had serious adverse effects (two convulsions, one infusion-related adverse event, one bronchospasm). Five (2.3%) patients were permanently discontinued from the study due to >1 treatment-related adverse effect. 

The earliest combination chemotherapy and radiation trials in nonsmall-cell lung cancer included cisplatin and 5-fluorouracil and concurrent radiation therapy and found survival results comparable to those for sequential chemotherapy and radiation or to daily cisplatin and radiation therapy without surgery (119,121). Phase II studies of stage Ilia and Illb nonsmall-cell lung cancer patients treated with the combination of cisplatin with etoposide and 5 -fluorouracil and either single daily radiation fractionation or twice daily radiation fractionation prior to surgery produced similar clinical results (119,121). Complete surgical resection was accomplished in 70% of the patients, the median survival was 22 mo and the 2-yr survival rate was 45%. 

Other phase designations have also become employed in various areas, including Phase Ila, Phase lib, and Phase Illb (see Buncher and Tsay, 2006a). However, these designations are not used consistently. Therefore, two studies with the same aims may be classified into different phases, and two studies classified into the same phase may have different aims. This nomenclature, therefore, can be confusing. An alternative system has been suggested by the ICH. 

In the later stages of the development of successful drugs, the interval between PLA or NDA filing and product launch is not wasted. The term phase Illb has been invented for the conduct of phase IV-type studies during the pre-approval period. Furthermore, in some companies, the old phase IV is now divided into phases IV and V, without any generally agreed definitions except, perhaps, that the studies are run by different teams. 

Gladyshevsky, Bodak and Pecharsky have collected together summaries of the literature of the last quarter century on phase equilibria and crystal chemistry of ternary metallic systems containing a rare earth element with a metallic member from the group III, Illb, or IV and a transition metal. This literature contains studies of a surprising fraction of the enormous number of compounds possible (i.e. crystal structure data for over 1600 ternary intermetallic compounds are presented and the phase relationships of nearly 200 ternary systems are illustrated, generally as isothermal sections). The authors have been major contributors to these investigations. 

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