Velleja Research | On-going researches
Research and Development in Biopharmaceuticals
Velleja Research » On-going researches
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On-going researches

Any scientific data, even if prompted by rational assumptions and/or hypotheses, must be ultimately the result of, and confirmed by, experimentation. The latter may be a simple in-vitro investigation (for example, on a cell culture), or a more complex in-vivo assay (on experimental animal models), ex-vivo study (on tissues taken from used experimental animal models) or clinical trials (on sound volunteers or individuals affected by a previously diagnosed disease). Trials may also be aimed at different purposes ? pharmacokinetic, pharmacodynamic or toxicological. Whatever the modus operandi, any experiment aimed at a cognitive investigation of a preparation ? which will then be marketed for nutraceutical, cosmeceutical or pharmaceutical use ? must be conducted with the exclusive use of the active ingredient available in the marketed finished form. This means that if one intends to develop a Vaccinium macrocarpon?based preparation to prevent E. coli-supported recurrent cystitis, the object of the trials will have to be the exact derivative that then will be used on the market. This will avoid falling into the all so common 'stolen science' trap, which is the presentation of data obtained from a raw material or ingredient that is similar, or even very much alike, but not identical or chemically superimposable to the raw material or ingredient that is the object of the marketing. On the contrary, today it is just the other way round ? for example, the proposition of a non-investigated Vaccinium macrocarpon?based preparation, accompanied by the scientific documentation of a Vaccinium macrocarpon derivative that is chemically different (from the points of view of its chemical profile, specifications, manufacturing process, etc.), is the object of the investigation of some researchers and has nothing to do with the preparation to be marketed. Obviously the above example with cranberry can also apply to the 'science of ingredients' used in formulations, and in particular those of nutraceuticals.
Unfortunately, the correct biunivocal correspondence between the active ingredient and the documentation provided is not enough to guarantee scientificity. This applies in particular to clinical trials, where the investigated preparation will have to be identical to the formulation to be promoted and marketed also with regard to its composition in excipients. Even simple variations in terms of its galenic formulation may lead to discrepancies between the observed and expected data, as they affect stability, kinetics and absorption rates.
For these reasons Velleja Research, thanks to an important network of scientific collaboration with Italian and foreign Universities, as well as clinical and hospital facilities, sets the toxicological, pharmacological, pharmacokinetic, pharmacodynamic and clinical verifications of preparations, very well defined in terms of their formulation and subject to possible future marketing, as the priority targets of scientific research.