Description
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Research trials in the field of pharmaceutical drug development , including: |
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Evaluation of the physical properties of the object in accordance with the requirements of the State Pharmacopoeia: a description of the appearance, an assessment of the melting temperature, pH , an assessment of solubility, etc. |
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Development of methods for the assessment of authenticity, including the determination of the chemical properties of the object of study as part of the selection of the reaction to determine the authenticity and storage conditions, the analysis of the IR spectrumwith a description of the absorption bands in accordance with the chemical structure |
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Development and Validation of Analytical Methods (HPLC) |
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Development and validation of analytical methods ( spectrophotometry , titration ) |
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The study of stability, the establishment of an expiration date in accordance with the requirements of the Global Fund XIII on three series ( by the method of accelerated aging ) |
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Study of stability, establishment of shelf life in accordance with the requirements of the GF XIII on three series (long-term studies) |
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Development of the project ND on the substance |
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Selection of the optimal dosage form (LF) and method of administration |
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Formulation of the composition of LF, the study of the compatibility of ingredients |
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Development of the project ND on the dosage form |
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Development of technology for production , development of the process and development of laboratory procedures for obtaining drugs |
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Development of technology for synthesis and production of experimental samples of asubstance for preclinical studies (total volume of accumulated batches is at least 400 g, excluding the cost of raw materials) |
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Development of technology for co-crystals , sample production, the study of their physico-chemical and biological properties (for 1 substance) |
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Development of technology for operating time and experienced LF samples (uncoated tablets: direct compression, wet granulation, dry granulated vanie) |
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Development of technology for operating time and experienced LF samples (film-coated tablets: direct compression, wet granulation, dry granulated vanie) |
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Development of technology for operating time and prototype LF (Pre-impregnated solidzhelatingovye ka) |
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Development of technology for production and production of prototypes of LF (soft gelatin capsules) |
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Development of technology for production and production of experimental samples of LF (solutions for injection / infusion ) |
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Development of technology for production and production of prototypes of LF (external soft LF - ointments, gels ) |
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Development of technology for production and production of prototypes LF (eye drops) |
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Development of recombinant protein production technology |
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H arabotka prototypes th recombinant protein for pre-clinical studies |
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Development of technology for production and production of prototypes of LF based on recombinant protein |
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Development of technology for producing isoforms of a substance, studying their physicochemical and biological properties (for 1 substance) |
