PROJECT OF BIOITECH

The Bioitech research project was founded in 1998 on the basis of scientific works on injectable tissue augmentation. The parties involved in this project have been able to count with the expert advice of the laboratiory of Biochemistry and Pharmacology, at some universities in southern Brazil.
The Implementing Plan of the research project has responded to some principles carried out at all stages of the process, from design to the finished product:
-Testing in the lab and clinical trial in compliance with the Helsinki Rules.
-Focusing on the clinical performance of the product.
-Particular attention given to security.
The first phase of the study was to examine all issues relating to the topic.
The requirements taken into consideration in the design phase, before the beginning of the realization of the product have been evaluated for completeness and adequacy in order to secure the expected requirements.
We have excluded from the study at beginning all polymers that once implanted in the body were not subject to total breakdown or absorption.
Experimental and clinical studies in this phase were brought forward in parallel.
Particular attention has been given to products with the same function, currently on the market.
We have also carefully studied the aspect concerning the filling, polymers with carrier function, the active principles and their possible forms: Hydrogel microspheres, suspension, etc.
We checked out, that the model initially proposed represents actually the best base in the light of the problems foreseen.
In any case, had been provided for some alternatives, able to overcome difficulties that could arise during subsequent stages of the trial.
The project has been realized in different phases:

Stage 1: Study of materials and existing products and/or alternative
Phase II: Laboratory Study on Guinea Pigs
Phase III: clinical study on patients
Phase IV: laboratory tests in accordance with EEC regulations
V stage: publication of patent, scientific publications and creation of Bioitech in order to industrialize the medical devices


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	PROJECT OF BIOITECH The Bioitech research project was founded in 1998 on the basis of scientific works on injectable tissue augmentation. The parties involved in this project have been able to count with the expert advice of the laboratiory of Biochemistry and Pharmacology, at some universities in southern Brazil. The Implementing Plan of the research project has responded to some principles carried out at all stages of the process, from design to the finished product: -Testing in the lab and clinical trial in compliance with the Helsinki Rules. -Focusing on the clinical performance of the product. -Particular attention given to security. The first phase of the study was to examine all issues relating to the topic. The requirements taken into consideration in the design phase, before the beginning of the realization of the product have been evaluated for completeness and adequacy in order to secure the expected requirements. We have excluded from the study at beginning all polymers that once implanted in the body were not subject to total breakdown or absorption. Experimental and clinical studies in this phase were brought forward in parallel. Particular attention has been given to products with the same function, currently on the market. We have also carefully studied the aspect concerning the filling, polymers with carrier function, the active principles and their possible forms: Hydrogel microspheres, suspension, etc. We checked out, that the model initially proposed represents actually the best base in the light of the problems foreseen. In any case, had been provided for some alternatives, able to overcome difficulties that could arise during subsequent stages of the trial. The project has been realized in different phases: Stage 1: Study of materials and existing products and/or alternative Phase II: Laboratory Study on Guinea Pigs Phase III: clinical study on patients Phase IV: laboratory tests in accordance with EEC regulations V stage: publication of patent, scientific publications and creation of Bioitech in order to industrialize the medical devices
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