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Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The(More)
OBJECTIVES To determine the predisposing factors, attack rate by underlying disease, and outcome of Pneumocystis carinii pneumonia among patients without the acquired immunodeficiency syndrome (AIDS) at a cancer center. DATA SOURCE Twelve-year retrospective review from a tertiary-care cancer center. STUDY SELECTION One hundred forty patients,(More)
BACKGROUND Patient satisfaction is the most important outcome in facial aesthetic surgery. However, the need for evidence-based evaluation of aesthetic procedures dictates the use of more objective and quantitative measures of treatment outcome. OBJECTIVE The present study was undertaken to validate a new clinical outcome instrument, the Wrinkle Severity(More)
  • Scott Gottlieb
  • 2008
PURPOSE The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the biopharmaceutical protein production process; scientific facts(More)