Pharma

GLP STUDIES PERFORMED BY CHELAB ASSAY CENTRE

Chemical - physical assays

Identity, pureness, chemical and physical characteristics of the substances
Chemical, physical and technical characteristics of the product and analysis for the determination of the composition

Toxicity studies

in vitro studies of skin irritation
in vitro studies of ocular irritation
in vitro studies of skin corrosion
in vitro studies of cytotoxicity
in vitro phototoxicity studies

Mutagenesis studies

Bacterial reversion test
Genic mutation in Saccharomyces cerevisiae
Miotic recombination: Saccharomyces cerevisiae
In vitro test of genic mutation on mammiferous cells
In vitro test of cromosomic aberration on mammiferous animals

Environmental toxicity studies (ecotoxicology) on terrestrial and aquatic animals

Growth inhibition test of algae
Acute toxicity for Daphnia - immobilization test
Acute toxicity for Vibrio fischeri
Test of inhibition plants growth
Acute toxicity for fishes

Studies on fate and behaviour in soil, air, water; bio-accumulation

Studies of biodegradation (primary biodegradability, immediate biodegradability, intrinsic biodegradability, aerobic biodegradability, complete biodegradability) and mineralization through:

CO2 development
Oxygen consumption
Exhaustion of dissolved organic carbon
Biochemical oxygen demand
Residue level of substances in biodegradated solutions
Identification of biotic and abiotic degradation products

Studies of aerobic and anaerobic degradation in soils and sediments
Aerobic mineralization in both superficial and marine water
Inhibition test of respiration in active muds and simulating test
Coefficiente di partizione ottanolo/acqua

Studies of residues

Xenobiotic residues (added, neoformated, included their metabolites and the products derived from their degradation or reaction) and of contaminants in treated products, vegetables, vegetable products, food and feed, biological liquid, human and animal tissues, vegetable-based products, raw materials, intermediate synthesis, semimanufactured, finished products, soil, water and air.

Chemical and analytical chemistry

Identification and dosage of active principles, impurities, degradation products, additives, flavours and other analytes in raw materials, semimanufactured and finished products, matrices of biological origin.
Study of residual depletion of chemotherapeutics in matrices of biological nature (only for the analytical part)
Compatibility studies of primary packaging in contact with the content.
Compatibility studies of active principles with vehicles and excipients
Study and validation of analytical methods

Metabolism and pharmacokinetics

Metabolism and pharmacokinetics (only for the analytical part): active principles and their metabolites, degradation products in matrices of biological origin (plasma, serum, urine, excrements, bile, organs, tissues, biological liquids, etc...).

Virus removal/validation of inactivation

Verification of virus removal; validation of inactivation

Other studies

Stability studies of raw materials, semimanufactured and finished products.
Evaluation of efficacy of disinfectants and antiseptic products

Antibactericidal activity studies
Fungicidal activity studies
Sporicidal activity studies
Mycobactericidal activity studies
Virucidal activity studies

Study for the determination of bactericidal endotoxins
Microbiological assays for sterility control
Microbiological assays for the control of obligatorily sterile products
Evaluation of preservative system efficacy
Evaluation and characterization of microorganisms (bioburden, species identification)

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