NanoViricides Inc. (NNVC)

[changes_iv]

Definition of Integrative and Organ Systems Pharmacology: "Pharmacological research using in vivo animal models or substantially intact organ systems that are able to display the integrated responses characteristic of the living organism that result from complex interactions between molecules, cells, and tissues."

AZ ABST Case Study
'ABST' stands for Automated Blood Sampler and Telemetry, the combined solution for integrative pharmacology. Through a collaborative effort between BASi, the maker of the Culex® Automated In Vivo Sampling System, and Data Sciences International (DSI), the gold standard in physiologic monitoring, it is now possible to collect more data from individual animals than ever before. ABST can be used to measure multiple variables in a single animal including heart rate, blood pressure, temperature, blood, urine and feces, dialysates, locomotion, activity and various biopotentials e.g. ECG, EEG, EMG, or ERG. Protocols requiring automated infusion can be easily incorporated and controlled with the BASi system. Contact BASi for further details.

Save Money
This combined system makes it possible to collect multiple streams of data simultaneously from individual animals. The ability to collect blood at the same time as other safety data eliminates the use of satellite groups. Subjects can be re-used after a washout period, leading to further reduction in the use of animals. Since the system is fully automated, it is possible to reduce staff hours compared to traditional methods. Additional money savings arise thanks to better data; the ABST makes it possible to make earlier go/no-go decisions so that money isn’t wasted on compounds that will not make it to market.

Save Time
The ABST system offers full automation for dosing, blood sampling, and the collection of safety data. This allows technicians to use time effectively, for example, an ABST experiment can commence in the morning, followed by a more time consuming manual PK study. Taking this approach can make your staff twice as effective as before. Elimination of satellite groups further reduces the amount of time that is spent on each compound. Finally, early decisions can be made with high quality data, reducing the overall time spent on non-viable compounds.

Gather Better Data
With satellite groups it is difficult to ensure that all study parameters are the same for each group. Indeed, manual pharmacokinetic sampling is often very stressful for research animals, while great care is taken to minimize human intervention during the collection of safety data. The ability to eliminate satellite groups with ABST allows for better control over study variables. Data collection is further refined by achieving a within subject experimental design and capturing inter-animal variability. Additionally, the ABST makes it possible to compare information across organ systems to determine time and exposure-dependent effects. All of these features make it possible to form early and informed decisions during drug development.

With the ABST, it is possible to simultaneously collect:
Urine/Feces for:

DMPK
Metabonomics
Clinical Pathology

Terminal tissue collections for:

Clinical Pathology
Molecular Toxicology

Other biofluids:

Bile
Dialysates

Telemetry Data including:

Heart Rate
Blood Pressure
Temperature
Locomotion
EMG, ERG, ECG or EEG


Serum/Plasma for:

DMPK
Metabonomics
Biomarkers
Clinical Pathology



http://www.datasci.com/solutions/integrated-pharmacology/automated-blood-sampler-and-telemetry

Other related source:

A modern in vivo pharmacokinetic paradigm: combining snapshot, rapid and full PK approaches to optimize and expedite early drug discovery.
http://www.ncbi.nlm.nih.gov/pubmed/22982770

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There are those who complain that the tox studies are delayed. I don’t believe that it is the case at all. Had our drug system not produced such amazing initial tox results, we would be well into the BASi studies at this time. The FDA mandates that we find the toxic dose. To do that requires an inordinate amount of material. When the amount of material needed is produced, the studies will start. I feel that it will be quite soon but I cannot, in good conscience, give a hard date.

There will always be a need and demand for vaccines, but many people won’t use them. We know this from experience. However, the existence of a nanoviricide treatment for a virus-borne illness means that treatment can begin after symptoms for influenza or some other virus-borne disease appear.

Based on animal studies, we believe that virus populations will be so reduced that symptoms would disappear in only a few hours. Immunity, however, would develop in the normal 21-day period so that the patient could not get the same infection again.

Some viruses—notably hepatitis, HIV, and herpes—might not be cleared entirely from the system because they hide inside various tissues. I believe, however, that symptoms will disappear, and the patient would not be contagious. When the virus emerges, however, it will encounter nanoviricides if they are in the patient’s system. Over time, there is a strong possibility that each reemergence will be smaller than the last, until the disease is gone. ~Mauldin Economics

http://www.mauldineconomics.com/download/transformational-wealth-from-three-tiny-companies