IPHARMA provides full cycle of clinical development from early phase trials to registration and post-marketing PV.

Services

Preclinical studies
Phase I and bioequivalence
Phases II-III
Pharmacovigilance
Trainings
Audits

IPHARMA conducts pre-clinical studies, develops and manufactures FDFs on the basis of a ChemRar hi-tech laboratory. Having a 25-year experience in the international drug development market, ChemRar  conducts pre-clinical studies in compliance with all international requirements and guidelines.

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Types of research

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1. High Throughput Screening 

  • Ion channels, GPCR, kinases, HDACs, viral polymerase and protease, etc.

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2. In vitro metabolism

  • Stability (microsomes and hepatocytes of mouses, rats, dogs, monkeys and humans)

  • Permeability (PAMPA test, Caco-2 cell line)

  • Solubility, lipophilicity, plasma protein binding

  • Interaction with the human cytochrome P450

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3. In vivo metabolism

  • Pharmacokinetics (LC / MS / MS high sensitivity)

  • Bioavailability, biodistribution

  • Study of Bioavailability and Bioequivalence

 

4. Pharmacology. Study of the pharmacological activity

  • CNS model, Parkinsonism

  • Obesity, violation of food and water consumption, type I diabetes

  • Anti-inflammatory and analgesic activity

  • Xenografts of human tumors

  • Antiviral activity (hepatitis C, influenza)

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5. Toxicology. The study of acute and chronic toxicity

  • Study of the general toxicity of substances (acute, sub-chronic, chronic)

  • Specific (allergenicity, immunotoxicity, reproductive toxicity)

  • Various species (SPF and non-SPF mice, rats, rabbits, minipigi)

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Organization of pre-clinical studies

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  • Clinical laboratory selection

  • Development of the protocol and other study documents

  • Safety monitoring

  • Quality assurance

  • Reports preparation