Archive for May, 2010

Study Sample To answer the study question, we randomly selected 2,187 physicians who were involved with at least one phase 3 clinical study as principal investigators at 2,897 clinical sites from January 1, 1995, to December 31, 1996. (Some physicians conducted studies for more than one indication.) For physician selection, we used a database that [...]

Phase 3 clinical trials are critical to new drug development because they help to secure regulatory approval for the new drugs and add to the general medical knowledge base. The published results from these clinical trials are important in the adoption of new drugs; key results relating to a new drug’s safety and efficacy appear [...]

The available evidence indicates that Sculptra™ is relatively safe. It is contra-indicated only for individuals with a known hypersensitivity to any of the components of the product.

A 24-week, randomized, open-label, single-center, non-control trial in London, UK, enrolled HIV-positive patients with facial lipoatrophy. The patients were randomly assigned to one of two study arms. Patients in the “immediate-treatment” arm received New-Fill® injections bilaterally overlying the buccal fat pads on day one and then two and four weeks later. Patients in the “delayed-treatment” [...]

Sculptra™ is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA). It is a biodegradable, biocompatible, and immunologically inert synthetic polymer derived from the alpha-hydroxy acid family.

Sculptra

1, May 2010

INTRODUCTION Human immunodeficiency virus (HIV) infection affects approximately one million persons in the U.S. alone. Along with recent advances in HIV treatment options, especially over the past decade, dramatic reductions in HIV-associated morbidity and mortality have been observed. As a result of an increase in life expectancy, however, the severity of side effects from these [...]

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