Toxicology

Standardized toxicological studies in support of the pharmaceutical industry and medical devices industry are developed, which are carried out in conjunction with global regulatory directives.

Species:

The usual strains for single-dose studies and repeated administration of drugs include Wistar rats, NMRI mice and Beagle dogs. We have, at the request of the client, other breeds and species of rodents. As a non-rodent species alternative, we use Large-white pigs, sheep and rabbits.

Routes of administration:

These include oral application (probing, diet and capsules), dermal or intraperitoneal, intravenous injection (bolus or infusion), intramuscular or subcutaneous, and inhalation.

The most common studies are:

• Single dose.
• Maximum tolerated dose.
• Local tolerance.
• Repeated Administration, 2, 4, 13, 26, 39 or 52 weeks.

Repeated administration studies can be designed with recovery groups and normally include toxicokinetic assessment.

Pharmacology Security

The JUMISC offers all studies and trials of pharmaceuticals and medical devices before the first administration or application to volunteers in Phase I trials:

• Central nervous system (Screening Test Irwin modified battery of tests observation from a functional point of view).
• Cardiovascular system (telemetric monitoring of animals).
• Respiratory system.

The customer can benefit from a series of complementary studies to evaluate pharmacological properties in all the major anatomical and physiological systems.

Pharmacokinetic studies

Made up of several regulatory requirements for the development of drugs, these are beginning to become an integral part of advance in drug discovery.

Species: Dogs, rabbits, dogs, pigs, sheep.

Roads: Oral, intraperitoneal, intravenous, subcutaneous, inhalation, intratracheal.
Simple and multiple administration. 

Obtaining blood samples: up to 8 samples of blood from a rat, handling the animals without causing them stress.

Bio-analytics.

Rapid development of the method: High processing samples.
HPLC/MS/MS, GC/MS, CE, RT-PCR

Pharmacokinetic analysis is done using non-linear regression software WinNonlin Professional v. 4.1.