【摘 要】
：
LMIS 50 mg is a sustained release depot formulation of leuprolide for subcutaneous injection.Study FP01C-13-001, entitled "An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic
【机 构】
：
Senior Vice President and Head of Development, Foresee Pharmaceuticals, USA
【出 处】
：
1st International Prostate Cancer Symopsium-2015、1st Interna
论文部分内容阅读
LMIS 50 mg is a sustained release depot formulation of leuprolide for subcutaneous injection.Study FP01C-13-001, entitled "An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of LeuprolideMesylate for Injectable Suspension (LMIS 50 mg) in Subjects with Advanced Prostate Carcinoma", is a global Phase 3 registration study currently ongoing in the US, Europe, and Asia.This presentation describes the study design, planning, and conduct with an emphasis on clinical and regulatory strategies to rapidly advance LMIS 50 mg to global registration through the 505b(2) pathway.Pharmaceutical development and supply chain issues will also be discussed.
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