Thursday, September 03, 2015 6:59:15 AM
http://www.nanoviricides.com/press%20releases/2015/Nanoviricides%20Reports%20that%20the%20FluCide%20Candidate%20was%20found%20to%20be%20Very%20Safe%20in%20cGLP-like%20Safety%20and%20Toxicology%20Study%20in%20Rats%20Performed%20by%20BASi.html
From TriPhase, a unrelated company dedicated to acquiring and developing novel therapeutics...
Analytical Data Drug Substance
Validated analytical methods are needed to support preformulation, formulation, and pharmacology studies, verification of doses used in GLP studies, cGMP manufacturing, and stability testing of clinical trial materials. It is typically assumed that analytical methods already exist for characterization and identification of the drug substance as this is common in the laboratory synthesis stage of drug discovery. To the extent they exist, the analytical methods must be validated as suitable for analyzing drug substance in the matrix.
If the methods do not exist or are found to be unsuitable for the analysis of drug substance, they will need to be developed as soon as possible so as not to jeopardize the progress of preclinical development.
The analytical method used previously for other [New Chemical Entity] NCE drug substance is likely to be suitable for this novel NCE. [High Performance Liquid Chromatography] HPLC with an external standard is the method of choice. Once validated for drug substance, these analytical methods must be adapted and validated for other sample matrix types, as needed, such as in vitro and in vivo dose samples (see also the bioanalytical method discussion), in-process testing, drug product release and stability testing, and cleaning samples. These methods need to be validated using protocols suitable for In-process development. In general, linearity, accuracy, precision, specificity, range, limit of detection/quantitation, and system suitability must be established. The presence of related substances will also be assessed qualitatively and quantitatively using area%.
Task 6 Analytical Data Drug Substance
6.1Prepare Reference Standard (5g)
6.2Characterize Reference Standard
6.3Document test methods
6.4 Set Drug Substance Specifications
6.5Stability studies of Drug Substance batches
GMP Manufacturing Drug Substance
After the synthesis of two non-GMP batches of drug substance, the synthetic methods should be sufficiently optimized and robust for transfer to the pilot plant if required for the synthesis of the GMP batch of drug substance. This batch, like the previous non-GMP batches, must be well characterized and also subjected to stability monitoring under ICH conditions.
This GMP material will be used for the manufacture of the
formulated drug for the definitive GLP safety toxicity studies including genetic toxicology testing.
The GMP batch will also be used for the manufacture of the clinical trial materials for use in a Phase I trial.
Task 7 GMP Manufacturing Drug Substance
7.1Drug Substance Technology Transfer
7.2Pilot scale GMP batch (1-2 kg)
7.3Quarantine, test, release GMP batch
7.4GMP batch stability monitoring
Develop Formulated Drug for Toxicology Studies
For conducting the in vivo studies detailed in this development plan, formulated drug will be required, including both oral and iv formulations. For all studies except GLP studies, the nonGMP batches will be used for preparing the formulated drug supplies.
The GMP batch will be used to prepare formulated drug for
all of the GLP safety toxicity and genetic toxicity studies required for the preparation of the IND package.
Note however that per the regulations, GLP studies may be conducted with non GMP drug substance providing suitable analytical methods and records are kept so as to be able to compare the quality of these non GMP batches to the quality of your proposed clinical batches.
Task 8 Develop Formulated Drug for Toxicology Studies
8.1Process scale-up solutions and other dosage forms
8.2Develop Specifications for solutions and other dosage forms
8.3Manufacture non-GMP toxicology formulated drug
8.4Analytical characterization of toxicology formulated drug
8.5Continuous stability monitoring of solution or other dosage forms
8.6Manufacture GMP toxicology formulated drug
8.7Stability monitoring GMP toxicology formulated drug
8.8Design prototype capsules (if
not completed above)
8.9Content, uniformity, dissolution, stability
8.10Initial stability monitoring
http://www.triphasepharmasolutions.com/Drug%20Development%20Plan.pdf
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus [3].
http://www.pharmamanufacturing.com/articles/2004/41/
c-GLP or GMP-like?...
Definitive Toxicology Studies
The definitive toxicology studies are a key part of the preclinical development package. Dose levels for the definitive studies will be selected based on the results from the pharmacokinetics and range-finding studies. The definitive toxicology studies must be performed under GLP conditions and (preferably) using GMP material in order to support the IND application.
http://www.triphasepharmasolutions.com/Drug%20Development%20Plan.pdf
http://www.nanoviricides.com/press%20releases/2015/Nanoviricides%20Reports%20that%20the%20FluCide%20Candidate%20was%20found%20to%20be%20Very%20Safe%20in%20cGLP-like%20Safety%20and%20Toxicology%20Study%20in%20Rats%20Performed%20by%20BASi.html
http://www.nanoviricides.com/2014-ceo-letter.pdf
The difference is subtle...
Facilities and Equipment. Although it generally is not necessary to fully qualify all equipment and validate all processes used in the manufacture of a product during its early development stages, it is important to document which equipment was utilized, why it was selected, and how it was used, cleaned, etc. If calibration of the equipment used to manufacture the product would typically be required in a GMP environment, a similar system is highly desirable at the research and development stage. In short, an intelligent evaluation of which pieces of equipment are critical to the operation should be made as soon as possible, and those critical pieces of equipment should be targeted to achieve compliance with "GMP-like" requirements by the time clinical-grade material is produced. Analogously, if the manufacturing process requires microbiologically-controlled facilities, it is prudent to measure and document the environmental control of these facilities to maintain product integrity and comparability.
Setting priorities for reaching compliance with GMP requirements is an integral part of product development planning. Once critical facilities and equipment have been identified, it is time to establish a schedule for generating compliance documentation. During product development, the move toward full compliance with Good Practice regulations is best regarded as a continuum, rather than a "now nothing, now everything" approach.
http://www.regulatory.com/forum/article/gdps.html
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=91019400
Today, that is a valuation of about $50 billion...
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Example of a FACT...
http://www.heritage.org/federalbudget/corporate-tax-rate
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