Wednesday, September 30, 2015 7:08:00 AM
Here are the facts:
http://www.fiercebiotech.com/press-releases/nanoviricides-retains-consulting-firm-expedite-first-flucide-human-trials-a
Any biotech do Phase 1, Phase 2, Phase 3 and possibly Phase 4 of human clinical trials but you are telling this forum that Preclinical/GLP cannot be divided into Phase 1, 2 and 3? Weak. Perhaps you may want to write Australian Biologics Pty, Ltd and then post here their reply/answer. Yes, you can!
Here is a company that did Preclinical studies in one fell swoop, as you claim!
NexBio...
-A small-biotech that is privately-held
-with Fludase a first-in-class Influenza drug
-government begins to grease skids for the small-biotech, Aug 8, 2005?
-a 50m contract with the NIH, fast-tracked
Why would a privately-held company, that seems to have everything going for them, would feel the urge to defraud the United States of America/taxpayers funded NIH? Cash-flow problems? with a 50m biologic-contract, how can that be?
source: http://www.sandiegouniontribune.com/news/2011/aug/04/feds-raid-san-diego-vaccine-developer/
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For a GLP inspector it should be possible to look at the documentation and to easily find out
who has done a study,
how the experiment was carried out,-
which procedures have been used, and
whether there has been any problem and if so
how it has been solved.
And this should not only be possible during and right after the study has been finished but also 5 to 10 or more years later.
Frequently the question comes: how much does this cost? It has been estimated that these additional organizational and documentation requirements increase operational costs of up to 30% compared to non-GLP operation.
The key requirements of a GLP type works are
-Responsibilities should be defined for the sponsor management, for study management and for the quality assurance unit.
-All routine work should follow written standard operating procedures.
-Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination.
-Test and control articles should have the right quality and instruments should be calibrated and well maintained
-People should be trained or otherwise qualified for the job
-Raw data and other data should be acquired, processed and archived to ensure integrity of data.
http://www.labcompliance.com/tutorial/glp/
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