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consulting-drug development-inlicensing-strategic decision guidanceExpert clinical advice for strategic decision makers in pharmaceutical drug development
http://www.allphasepharma.com/
Expert clinical advice for strategic decision makers in pharmaceutical drug development
http://www.allphasepharma.com/
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consulting-drug development-inlicensing-strategic decision guidance | allphasepharma.com Reviews
https://allphasepharma.com
Expert clinical advice for strategic decision makers in pharmaceutical drug development
allphasepharma.com
FDA cUTI Guidance 2015 is a mixed bag
http://www.allphasepharma.com/dir/2015/03/15/1301/the-new-cuti-guideline-a-look-at-the-evolving-thinking-at-fda
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Did you know…? Did you know…? Did you know…? Did you know…? The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA. March 15, 2015. No Comments ↓. In what respect is the new cUTI Guidance different from earlier versions? Where is the impact of ‘new science’ that triggered a ‘rethinking’ of the regulatory approach to cUTI? Aren’t these two things linked? And does it really matter if urgency persist on Day 1...
consulting-drug development-inlicensing-strategic decision guidance
http://www.allphasepharma.com/dir
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Did you know…? Did you know…? Did you know…? Did you know…? Now, I know we should not make light of any IDSA Guidelines, far from it. This latest, the Aspergillus Guideline [1], like others before, is a thoughtful document which reviews the newest information and reflects expert authoritative thinking on the Continue reading Aspergillus Guideline.ZIP. Is LAIV Dead or Just on LAIV-Support? The old-fashioned portable ...
ceftaroline trials in CABP show drug efficacy and savvy development
http://www.allphasepharma.com/dir/2015/02/11/1265/commenting-on-comments-the-ceftaroline-trial-program-in-cabp
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Did you know…? Did you know…? Did you know…? Did you know…? Commenting on Comments: The Ceftaroline Trial Program in CABP. February 11, 2015. No Comments ↓. Conducting anti-infective trials during this time was not for the faint of heart, and any of the newly introduced criteria could have ‘sunk’ the ceftaroline NDA submission. However, ceftaroline passed the AIDAC review (Sept. 2010) with flying colors [2]. He make...
Strategic assessments-negotiation-licensing evaluations-Medical Affairs
http://www.allphasepharma.com/dir/expertise
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Did you know…? Did you know…? Did you know…? Did you know…? BD and M&A evaluations:. Providing sound judgment where it matters most! Negotiation with Health Authorities:. Integrating scientific / clinical / regulatory know-how for success. Developing TPPs / CDPs with an eye on feasibility. Early efficacy/safety read-outs for streamlined development. Avoiding project commitments with low likelihood of success. The Cr...
campylobacter and ciprofloxacin resistance
http://www.allphasepharma.com/dir/2015/04/21/1385/an-inconvenient-truth-ciprofloxacin-resistant-campylobacter
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Did you know…? Did you know…? Did you know…? Did you know…? An Inconvenient Truth: Ciprofloxacin-Resistant Campylobacter. April 21, 2015. No Comments ↓. When Al Gore became a best-selling author with An Inconvenient Truth he warned about climate change. When it comes to antibiotic resistance and the current situation of Bad Bugs, No Drugs , there are many voices warning us about a return to the pre-antibiotic era.
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consulting-drug development-inlicensing-strategic decision guidance
Allphase Pharma Consulting, LLC. A Professional Service Provider for the Pharma Industry. Skip to primary content. Skip to secondary content. Skip to primary content. Skip to secondary content. Did you know…? No Easy Day: Dose Calculations for Aminoglycosides and Vancomycin. No Such Thing as a Free Ride. A Renaissance for Old Drugs: Fosfomycin and Colistin. Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Cresemba / Isavucona...
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