'Clinical benefit' diaporamas de présentation

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NDA 21-399 ZD1839 for Treatment of NSCLC FDA Review Division of Oncology Drug Products

NDA 21-399 ZD1839 for Treatment of NSCLC FDA Review Division of Oncology Drug Products. FDA ZD1839 NDA Review Team. Outline of FDA Presentation. Regulatory Overview and Critical Issues Grant Williams, MD Medical Review Findings Martin Cohen, MD Statistical Review Findings

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Antiplatelet Therapy in General Overview

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Zarnestra NDA 21824

Zarnestra NDA 21824. Qin Ryan MD, PhD DODP/CDER/FDA. Outline. Regulatory Background Clinical Overview and Proposed Indication CTEP-20 Design CTEP-20 Efficacy CTEP-20 Safety Summary. Regulatory Background. Regulatory Background.

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A Tale of Two Cities

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Surrogate Endpoints: A Regulatory View

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Defining Success in Oncology Drug Development

Defining Success in Oncology Drug Development. Richard Pazdur, MD CDER, FDA The views expressed are the results of independent work and do not necessarily represent the views or findings of the United States Food and Drug Administration or the United States. Basis for NDA Approval.

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MEASURING CLINICAL EFFICACY IN PHASE II TRIALS

MEASURING CLINICAL EFFICACY IN PHASE II TRIALS. Response: Karnofsky, WHO, RECIST Event rate: progression free/survival Time to event: progression/survival Functional imaging Mutational analysis-biomarkers. Endpoints Used in SWOG Phase II Trials.

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Treatment as Prevention: Research, Policy, and Best Practices

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#Abst1097#

#Abst1097#. wALT trial (Phase I-II): Weekly non- pegylated liposomal anthracycline and taxane combination in first-line breast cancer chemotherapy.

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Phase II Study of Dasatinib (BMS-354825) in Advanced Sarcomas and Chordoma

Phase II Study of Dasatinib (BMS-354825) in Advanced Sarcomas and Chordoma. Coordinating Center: U Michigan. Probability of response to imatinib (95% posterior credible intervals). Rationale for trial: extension of results from imatinib in sarcoma.

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LymphoStat-B TM A Case Study for Endpoints and Trial Design in SLE

LymphoStat-B TM A Case Study for Endpoints and Trial Design in SLE. Presentation to the Arthritis Drugs Advisory Committee 30 September 2003 Bill Freimuth, MD, PhD. Agenda. Review BLyS and the pharmacologic rationale, nonclinical and clinical data for LymphoStat-B

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Regulatory Considerations for Endpoints

Regulatory Considerations for Endpoints. Ann T. Farrell, M.D. FDA/CDER/DODP. Requirements for Drug Approval. Safety (FDAC 1938) Efficacy established in adequate and well-controlled investigation s (FDAC 1962) Use of data from one trial plus supportive evidence (FDAMA 1997).

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Highlights of the Day-Plenary Session<br /><br />June 1, 2014<br /><br />Lowell E. Schnipper, M.

Highlights of the Day-Plenary Session<br /><br />June 1, 2014<br /><br />Lowell E. Schnipper, M.D. Presented By Lowell Schnipper at 2014 ASCO Annual Meeting. Why invite a value discussion?. Presented By Lowell Schnipper at 2014 ASCO Annual Meeting.

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Rare Disease Workshop 5: Post Marketing Confirmatory Studies in Rare Diseases

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Figure 4 Pathological assessment of immune effector cells associated with melanoma brain metastases following ipilimumab treatment. Hodi FS et al . (2008) CTLA-4 blockade with ipilimumab induces significant clinical benefit in a female with melanoma metastases to the CNS

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Figure 3 Pathological examination of resected brain metastasis following ipilimumab treatment.

Figure 3 Pathological examination of resected brain metastasis following ipilimumab treatment. Hodi FS et al . (2008) CTLA-4 blockade with ipilimumab induces significant clinical benefit in a female with melanoma metastases to the CNS Nat Clin Pract Oncol doi:10.1038/ncponc1183.

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