clinical development plan

clinical development plan

A document describing the clinical studies that must be performed during the development of a particular active substance, device, procedure or treatment strategy, typically with the intention of submitting the study data as part of an application to the FDA for marketing authorisation. The plan should indicate appropriate decision points and allow for trial modifications as knowledge accumulates.
References in periodicals archive ?
This is an important step in our clinical development plan for GLPG0634 said Piet Wigerinck, CSO of Galapagos.
OxThera is currently discussing a complete clinical development plan for Oxabact[sup.
MultiCell has scheduled a meeting with the MHRA for December 1, 2006, to present the company's clinical development plan for the Phase IIb of MCT-125.
A good clinical development plan will ensure success throughout the product lifecycle.
Fisher will present scientific data and a clinical development plan update of the Company's lead candidate, NPT088, which utilizes GAIM (General Amyloid Interaction Motif) technology to target multiple types of misfolded proteins found in many diseases of aging, such as Alzheimer's and Parkinson's diseases.
InCode is pursuing a progressive clinical development plan focused on proof of concept trials.
It is also a significant step forward in Biothera's overall clinical development plan for Imprime PGG.
Fisher will present scientific data and clinical development plan update of the Company's lead candidate, NPT088, which utilizes GAIM (general amyloid interaction motif) technology to simultaneously target multiple types of misfolded proteins found in many diseases of aging, such as Alzheimer's and Parkinson's diseases.
Review current clinical development plan to evaluate PEGPH20 in two Non-Small Cell Lung Cancer trials, in combination with chemotherapy and then with a PD-1 inhibitor -
Simes will discuss, on Tuesday, November 4, 2008 at 9:20 am EST at the Oppenheimer Conference and on Wednesday, November 12 at 9:30 am EST at the Rodman & Renshaw Conference, the LibiGel([R]) (testosterone gel) clinical development plan and primary research data indicating the potential multi-billion dollar size of the U.
Simes will discuss, on Thursday, October 30, 2008 at 8:30 PDT, the LibiGel[R] (testosterone gel) clinical development plan and primary research data indicating the potential size of the U.
Simes will discuss the LibiGel([R]) (testosterone gel) clinical development plan and new primary research data indicating the potential size of the U.
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