Non-clinical in vivo safety and pharmacological testing  

• GLP and non-GLP in – vivo studies to support preclinical development and CTA/MA processes
• Custom tailored or standard safety testing programs
• Test Items: Human and veterinary medicinal products, food supplements, medical devices
• Test systems: mouse, rat, guinea pig, rabbit (non rodents in collaboration with Pigmod centre)
• Administration routes: common administration routes (oral, intravenous, intradermal, intramuscular, intraperitoneal, subcutaneous)
• Test Guidelines: ICH, OECD, EMA, ISO
• Acute toxicity, MTD studies (GLP/non-GLP)
• Repeated dose, DRF studies (GLP/non-GLP) 
• PK and ADME (Bio-distribution) studies (GLP/non-GLP)
• Proof of Concept studies (Pharmacology)
• In vivo biocompatibility studies (for medical devices)
• Hematological testing of blood / plasma / serum from test animals - TECHNICAL DETAILS​
• Gross pathology evaluation
• Histopathology
• Consultancy on design of preclinical activities

Typical non-clinical safety study workflow:

1. Drafting and approval of Study plan
2. Animals: intake, entry veterinary examination, randomization, acclimation
3. Test Item  (TI) receipt, Identification, sampling
4. Takeover of Test Item and proper storage
5. Preparation of application form + administration to animals
6. Daily observation, weighing, blood sampling of test animals
7. Gross pathology observations
8. Histopathology
9. Final Report

Before starting detailed discussion on study design, please give us information on your intention, basic study design (animal species, number of animals/groups, administration route, information on item to be tested) and any other information that can help us understand your needs. Put all this information into Message window below and send it to us. We will respond promptly.

Production of whole blood, plasma, serum and rabbit complement, guinea-pig complement

Whole blood

• Blood sampling with anticoagulant

Plasma

• Blood sampling with anticoagulant,
• Centrifugation,
• Supernatant liquid sampling = plasma
• Freezing

Serum

• Blood sampling without any anticoagulant,
• Centrifugation,
• Supernatant liquid sampling = serum
• Freezing

Complement

• Preparation of complement
• The Rabbit complement is supplied frozen, package of 1ml or 2ml

Immunization of animals and hyperimmune sera preparation

Download:

CERTIFICATE OF GOOD LABORATORY PRACTICE (GLP) for non-clinical testing of Pharmaceuticals 

Accreditation Certificate for users issued by Central Committee for Animal Protection of the Czech Republic OBK