Guidance for Industry and Review Staff Target Product Profile - FDAShare on:
Mar 9, 2007 ... The name given to this template was the target product profile. Experience with TPP-focused meetings with sponsors at the FDA has indicated ...
Defining your target product profile
A target product profile (TPP) is a key strategic document that provides a summary of the following: ... a format for discussion between a sponsor and the FDA.
medical de vice - Premier Research
The Target Product Profile (TPP), a concept originally aimed at ... The TPP is a common template that can be used for all products across a company portfolio to ...
Target Product Profiles - ADRclinresearch.com
A Target Product Profile (TPP) is a ... The FDA has prepared a Template included in a ... “The target label language in the TPP helped me evaluate and.
Target Product Profiles_v041009.pdf
Target Product Profile (TPP) Process - Critical Path Institute
A Target Product Profile (TPP) is a strategic development tool which summarizes a ... The TPP document format correlates each development goal to planned or ...
Sample A: CIRM TARGET PRODUCT PROFILE (TPP) TEMPLATE
Sample A: CIRM TARGET PRODUCT PROFILE (TPP) TEMPLATE. TARGET PRODUCT PROFILE for. <Delete this text and type Name of your Product/ Therapy ...
Supplement RFA10-05_SAMPLE A_TPP.pdf
The Target Product Profile - QB3
Mar 16, 2012 ... Module 2: The Target Product Profile and Its Role in Drug ..... Minimal. Teaching Point 3: Although the TPP concept and format from company to.
Target Product Profile - World Health Organization
Oct 3, 2014 ... Target Product Profile for Zaïre ebolavirus rapid, simple test to be used in ... For example, antigen detection tests in an RDT format may play a.
Target Product Profile: HIV Self-Test Version 4.1 - Path
May 22, 2014 ... Target Product Profile: HIV Self-Test Version 4.1: A White Paper on ..... Duration of valid sample (time from taking sample to insertion in device) .
The Target Product Profile - Global HIV Vaccine Enterprise
Nov 5, 2015 ... template to use during drug ... FDA Guidance for Industry “Target Product Profile – A Strategic ... indication, target population, product.
Module #2 Drug Development Strategy
Apr 15, 2014 ... Return of Investment (ROI). ✓. Target Product Profile (TPP). ✓ ...... the score is, the important it is.) SUM. WEIGHING SYSTEM TEMPLATE. 56 ...
20140415_Drug Development_PreClin_FTIM_10April 2014_final2(for posting).pdf
Target Product Profiles of Tuberculosis - one size fits all?
Obtaining a sample. X out TB. Breslauer PLOSone 2009. Diversity of possible strategies: Moving the test to the patient. Doctor gets result. Patient gets result ...
Beginning with the goal in mind: our strategic approach to Betalutin
Design a Target Product Profile that will .... which translated into a differentiating Target Product Profile ... CLINICAL PHASE OBJECTIVES AND SAMPLE SIZE.
Marco Renoldi - Cap Mkts Day 17 11 15.pdf
Available Online through - International Journal of Pharmacy and
Apr 10, 2015 ... A Target Product Profile (TPP) is a strategic development tool which ... The working group recommended use of a template that provides a ...
Meeting Regulatory Challenges for Cell-Based Therapies
therapeutic product profile (TPP). This can help you ... Many aspects of a final product are .... Figure 1: example of a target product profile worksheet. Target ...
Roche Template - Medical Cluster
Resulting product formats can be; ... Pharma are often working within the “ Combination Product” environment (per FDA) .... Target Product Profile/Technical TPP.
FDA's Question-based Review
Dec 5, 2013 ... question: Did the product do what I expected .... QbR is the Backbone of our Review Template. 16 .... Quality target product profile (QTPP).
Lifecycle Approach to FDA's Structured Benefit-Risk Assessment - Bio
FDA's review templates, FDA and sponsors can understand and .... be used as a tool in the same way that the Target Product Profile is used, and would not be.
MPT Intravaginal Ring Target Product Profile - IMPT
Apr 1, 2015 ... MPT Intravaginal Ring Target Product Profile. Product Name: ARV + HC MPT IVR . Please note: This dosage form TPP is designed to serve as a ...
Contraceptive Target Product Profiles and Research Gaps
Contraceptive Target Product Profiles and. Research Gaps. Future of Contraception Initiative. October 31, 2011. © 2011 Bill & Melinda Gates Foundation.