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Mammalian and Genetic Toxicology
SIPRA has good experience in supporting clients with excellence in the management of toxicology studies in rodent and non-rodent species, all accompanied by on-time reporting. A certified team of study directors work closely with our clients to ensure that studies are conducted to meet both product development and international regulatory needs. The service is supported by a dedicated pathology group and laboratory animal specialists. In addition, all protocols are designed to meet the regulatory requirements of the various countries in which the products are to enter clinical trials or be marketed.
Mammalian Toxicology
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- Single dose (Acute ) toxicity
- Eye Irritation / corrosion
- Repeated dose (28, 90 & 180 Days)
- Endotoxin test
- Carcinogenicity
- Skin Irritation / corrosion
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- Immunotoxicity
- Skin Sensitization
- Reproductive toxicity
- Toxicokintics
- LD50 and maximum tolerated Dose determination
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Genetic Toxicology
- Ames test
- Micronucleus test
- Chromosome Aberration
Pharmacological Service
Absorption, Distribution, Metabolism & Excretion (ADME)
ADME studies provide valuable insight into a drug’s profile in vivo, as well as a preview of what may be observed clinically. We offer GLP-compliant ADME through validated test systems to support international regulatory requirements. Experienced staff and dedicated team are involved in all aspects of study conduct to ensure all essential information is properly analyzed.
Pharmacokinetics
We have established experience conducting pharmacokinetic (PK) studies including drug half-life, biodistribution, bioavailability and safety evaluation. We offer bioanalytical methods of development and validation to identify and quantify test articles, metabolites and degradation products in blood, urine and other biological fluids or tissues.
Safety Efficacy Studies
We provide expert services according to the corresponding guidelines, the nature and construction of the device, its use, as well as its mode and duration of patient contact. Surgical implant procedures are performed by our experienced staffs.
Efficacy Studies
- In-vivo Diabetes
- In-vivo Aphrodisiac
- In-vivo Anti-inflammatory
- In-vivo Antiulcer
- In-vivo Adaptogenic
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- In-vivo Cholesterol lowering
- In-vivo Immunomodulatory
- In-vivo Anticancer
- In-vivo Drug Interaction
- In-vivo Antioxidant
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Drug Metabolism & Pharmacokinetic Studies
- Permeability (Caco2, MDCK)
- CYP Mediated Metabolism
- Protein Binding
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- Microsomal Metabolic Stability
- PK & Routs of Excretion
- 14C Studies (Mass Balance)
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Safety Pharmacology
- Core Battery
- CNS - G. Behavior
- Motor Coordination
- Locomotor
- Exploration
- CVS – Blood Pressure
- Heart Rate
- ECG (QT-Interval)
- Respiratory- Tidal Volume
- Respiratory Rate
- Minute Volume
Studies are conducted in the following species:
- Wistar rats
- Swiss albino mice
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- New Zealand white rabbits
- Beagle Dogs
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