Methodological Considerations in the Design and Implementation of Clinical Trials

Cluster randomised trials : Methodological and ethical considerations

Considerations in the design of clinical trials for erectile dysfunction

The naissance of the phosphodiesterase-5 inhibitors has dramatically fueled the research engine in pursuit of novel therapies for erectile dysfunction (ED). The epidemiological product of reports on penile implants, to multicenter, randomized, double-blinded, placebo-controlled trials on oral therapy and intracavernosal/intraurethral injection therapy, has translated into substantial assets for...

the analysis of the role of the speech acts theory in translating and dubbing hollywood films

از محوری ترین اثراتی که یک فیلم سینمایی ایجاد می کند دیالوگ هایی است که هنرپیش گان فیلم میگویند. به زعم یک فیلم ساز, یک شیوه متأثر نمودن مخاطب از اثر منظوره نیروی گفتارهای گوینده, مثل نیروی عاطفی, ترس آور, غم انگیز, هیجان انگیز و غیره, است. این مطالعه به بررسی این مسأله مبادرت کرده است که آیا نیروی فراگفتاری هنرپیش گان به مثابه ی اعمال گفتاری در پنج فیلم هالیوودی در نسخه های دوبله شده باز تولید...

Statistical Considerations in the Design of Biosimilar Cancer Clinical Trials.

When the patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioe...

Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities

The heightened safety concern was precipitated by repeated reports on torsade de pointes (TdP) and other arrhythmias occurring in patients treated with an antihistamine drug (terfenadine) [1]. ECG measurements performed during the clinical development process by cardiologists (allegedly using "eyeball/calliper" techniques), have failed to identify drug-related QT prolongation. The false-negativ...