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Thursday, September 10, 2015 7:17:43 AM
Phase 1 - Will likely involve a small number of participants where a range of dosage levels are tested and any side effects analysed. Dosing will likely take a week.
I'd say (4) weeks...
The usual review cycle takes only 4 to 8 weeks and is based on the submission of a protocol, investigator brochure and if required, an independent toxicology report.
https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-australia#F
News are coming that will reverse the downward trend, that is why you are arguing Phase 1 Clinical Trials.
You should already know that Phase 1 and Phase 2 GLP tox studies have demonstrated low toxicity. Phase 3 won't be any different. "PEG has a toxicological profile of very low concern and is well tolerated at high doses after chronic and acute administration." http://dmd.aspetjournals.org/content/35/1/9.full
We should only be happy that FluCide(TM) is highly effective to make short trials possible.
"by the way, I'm sure that when you think human trials for drugs you think of hundreds of millions of dollars and years of time, well in this case because the disease only lasts a week, two weeks,...that it is possible to complete human trials in the space of a few short months...four parts to the human trials" ~ Dr. Eugene Seymour, CEO Nanoviricides, Inc.
...then on the CEO letter he went to explain how would this be possible:
The number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.
http://www.nanoviricides.com/2014-ceo-letter.pdf
Shortly after Phase 1 comes Phase 2 Clinical Trials and that is when NNVC nav will skyrocket...and we are going to be hi-ii-iigh as a kite by then...!!
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About Parallel microfluidic synthesis of size-tunable polymeric nanoparticles using 3D flow focusing towards in vivo study(2014)
Abstract
Microfluidic synthesis of nanoparticles (NPs) can enhance the controllability and reproducibility in physicochemical properties of NPs compared to bulk synthesis methods. However, applications of microfluidic synthesis are typically limited to in vitro studies due to low production rates. Herein, we report the parallelization of NP synthesis by 3D hydrodynamic flow focusing (HFF) using a multilayer microfluidic system to enhance the production rate without losing the advantages of reproducibility, controllability, and robustness. Using parallel 3D HFF, polymeric poly(lactide-co-glycolide)-b-polyethyleneglycol (PLGA-PEG) NPs with sizes tunable in the range of 13-150 nm could be synthesized reproducibly with high production rate. As a proof of concept, we used this system to perform in vivo pharmacokinetic and biodistribution study of small (20 nm diameter) PLGA-PEG NPs that are otherwise difficult to synthesize. Microfluidic parallelization thus enables synthesis of NPs with tunable properties with production rates suitable for both in vitro and in vivo studies.
FROM THE CLINICAL EDITOR:
Applications of nanoparticle synthesis with microfluidic methods are typically limited to in vitro studies due to low production rates. The team of authors of this proof-of-principle study reports on the successful parallelization of NP synthesis by 3D hydrodynamic flow focusing using a multilayer microfluidic system to enhance production rate without losing the advantages of reproducibility, controllability, and robustness.
http://www.ncbi.nlm.nih.gov/pubmed/23969105
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