			Home About us Contact

Drug Administration Approval (drug + administration_approval)

Distribution by Scientific Domains

Medical Sciences	75%

Selected Abstracts

REVIEW: Developing human laboratory models of smoking lapse behavior for medication screening

ADDICTION BIOLOGY, Issue 1 2009
Sherry A. McKee
ABSTRACT Use of human laboratory analogues of smoking behavior can provide an efficient, cost-effective mechanistic evaluation of a medication signal on smoking behavior, with the result of facilitating translational work in medications development. Although a number of human laboratory models exist to investigate various aspects of smoking behavior and nicotine dependence phenomena, none have yet modeled smoking lapse behavior. The first instance of smoking during a quit attempt (i.e. smoking lapse) is highly predictive of relapse and represents an important target for medications development. Focusing on an abstinence outcome is critical for medication screening as the US Food and Drug Administration approval for cessation medications is contingent on demonstrating effects on smoking abstinence. This paper outlines a three-stage process for the development of a smoking lapse model for the purpose of medication screening. The smoking lapse paradigm models two critical features of lapse behavior: the ability to resist the first cigarette and subsequent ad libitum smoking. Within the context of the model, smokers are first exposed to known precipitants of smoking relapse (e.g. nicotine deprivation, alcohol, stress), and then presented their preferred brand of cigarettes. Their ability to resist smoking is then modeled and once smokers ,give in' and decide to smoke, they participate in a tobacco self-administration session. Ongoing and completed work developing and validating these models for the purpose of medication screening is discussed. [source]

Hemostatic complications of angiogenesis inhibitors in cancer patients,

AMERICAN JOURNAL OF HEMATOLOGY, Issue 11 2008
Francesca Elice
Tumor vasculature and tumor-associated neo-angiogenesis have recently become major targets for rational drug design of antineoplastic agents. Five such agents with angiogenesis inhibiting activity (thalidomide, lenalidomide, bevacizumab, sunitinib, sorafenib) have already obtained US Food and Drug Administration approval for clinical use and many others have entered clinical trials. Vascular complications, including venous or arterial thromboembolism and hemorrhage, have emerged as relevant toxicities in several clinical trials with angiogenesis inhibitors. Given the well-known interplay between the blood clotting system, angiogenesis, and tumor growth, a better understanding of the impact of these new drugs on overall hemostatic balance is required. In this brief overview, we discuss the incidence of hemostatic complications, the likely pathogenetic mechanisms involved, and the critical need to establish in randomized clinical trials the usefulness of thrombosis prophylaxis to prevent these complications. Careful documentation of hemostatic complications during treatment with each of the new antiangiogenic drugs is warranted. Further studies are urgently required to better define the causal association of these new agents with hemostatic complications and to establish the best prophylactic strategy. Am. J. Hematol., 2008. © 2008 Wiley-Liss, Inc. [source]

Pivotal studies of orphan drugs approved for neurological diseases,

ANNALS OF NEUROLOGY, Issue 2 2009
Jun Mitsumoto MPH
Objective To identify design elements of clinical trials leading to US Food and Drug Administration approval of drugs for neurological diseases with and without orphan indications. Methods We used publicly available information to identify approvals for drugs for neurological diseases with an orphan indication (n = 19) and compared them with recent approvals for drugs for neurological diseases without an orphan indication (n = 20). We identified "pivotal trials" from drug labels and drug approval packages, and assessed them on four elements of clinical trial design: control, blinding, randomization, and size. Results All drugs for neurological diseases (100%) approved without an orphan indication included at least two randomized, double-blind, placebo-controlled trials. In comparison, 32% of drugs with an orphan indication had at least two such trials (p < 0.001) and 74% had at least one (p = 0.02). Thirty-three pivotal trials were conducted for the 19 drugs approved with an orphan indication. Of the 33 trials, 11 (33%) did not use a placebo control, 9 (27%) were not double blind, and 4 (12%) were not randomized. Drugs approved without an orphan indication had more pivotal trials per drug (3.8 vs 1.7 trials; p < 0.001) and a larger mean trial size (506 vs 164 trial participants; p < 0.001). Interpretation The US Food and Drug Administration has approved orphan drugs for neurological diseases without randomized, doubled-blind, placebo-controlled pivotal trials. As orphan drug development grows, demand will likely increase for alternative designs for conducting adequate and well-controlled studies to demonstrate drug efficacy. Ann Neurol 2009;66:184,190 [source]

Optimal Moving Angle of Pusher Plate in Occlusive-Type Pulsatile Blood Pump

ARTIFICIAL ORGANS, Issue 7 2010
Hyuk Choi
Abstract Since the occlusive-type pulsatile extracorporeal blood pump (Twin-Pulse Life Support System; Seoul National University, Seoul, Korea) received the CE mark of the European Directives and Korea Food and Drug Administration approval (2004) for short-term applications as an extracorporeal life support system, the pump system has been tested for hemolysis. This pump system was recently upgraded with an ameliorated pusher plate to reduce hemolysis. In this study, numerical analysis and in vitro tests were performed to determine the optimal conditions for increasing the durability of the blood sac and pump output. During the simulation, the minimum sliding interface force (SIF) for the angle of the pusher plate movement (PPM) was calculated (40,70°). In the in vitro durability test, the angle of the PPM was increased gradually from 40 to 70° in 10° increments, and the mean time to failure (MTTF) of the blood sac was calculated. Fifteen tests were conducted for each case: 40, 50, 60, and 70° (n = 15 each). The MTTF of the blood sac was defined as the time when a crack of the blood sac occurred. The longer lifetime of the blood sac at 60° of the PPM (297.0 h) than that at 50° (197.6 h) was attributed to the lower SIF value (,0.13, normalized value) at 60° of the PPM. [source]