Trusted Preclinical Research Partner

R&D & Exploratory studies

The development of preclinical models is essential for the successful and safe launch of a new drug. These models serve as a “testbed” in which efficacy, safety and mechanism of action are tested.

Projektová tabulka

Project	Planning	Data collection/Evaluation	Internal validation
Chronic glaucoma in dogs
Osteoarthritis in dogs
Human influenza model in ferrets
Osteoarthritis in rabbits

Exploratory toxicology studies including PK/PD/BA/TK are a key tool in the early stages of drug development. Their main goal is to identify and define preclinical efficacy, tolerability and potential toxic effects before proceeding to larger and more expensive studies. These studies do not require GLP.

MTD & DRF, pilot, Proof-of-Concept single & repeated dose studies, rodent & non-rodent species

Pharmacokinetic and pharmacodynamic studies are essential for evaluation and optimization of candidate molecules (determination of bioavailability, dosing optimization, determination of metabolites, prediction of behaviour in man). Selection of animal model is crucial; candidate drug shall be pharmacologically active in the model selected.

Single & repeated dose, parallel/cross-over design, rodent & non-rodent species

IND-enabling studies

The task of IND-enabling studies (Investigational New Drug Application) is to demonstrate that a new drug is safe enough for its first human use. These are key preclinical studies that form the basis of regulatory documentation for entry into the clinical phase of development.

Single & repeated dose studies including TK evaluation, rodent & non-rodent species

General toxicology, systemic & local

Extended single dose and single dose studies, as well as repeated dose studies including TK and/or safety pharmacology end points

Safety pharmacology

Examination of the effect on vital functions – e.g. cardiovascular, respiratory and central nervous systems

Single & repeated dose studies, rodents (respiratory & central nervous systems), dogs (cardiovascular system)

Local effects

A local tolerance study is an important part of the preclinical evaluation of drugs, especially those that are administered parenterally (e.g., by injection, transdermally, intramuscularly). Its goal is to determine how the test substance acts at the site of application - i.e. whether it causes irritation, inflammation, necrosis, or other adverse local reactions.

Single & repeated dose studies, rodent & non-rodent species

Non-clinical safety

Preclinical evaluation of vaccine candidates, biotech-derived/synthetic products, anticancer pharmaceuticals, non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals

Single & repeated dose studies including TK evaluation, rodent & non-rodent species

Supporting services

Clinical pathology
Histopathology
Veterinary surgery
BSL II conditions for small animals
GMO and psychotropic substance handling

Species	Non-rodent: Dogs, cats, rabbits, ferrets, pigs/mini pigs, NHP Rodent: Mice, rats, hamsters, guinea pigs
Effect	Systemic & local
Administration routes	Oral, buccal, sub-lingual, intra-venous, intra-muscular, intra-peritoneal, intra-cardial, intra-dermal, intra-nasal, intra-tracheal, intra-articular, intra-vitreal, rectal, vaginal, dermal, sub-cutaneous, ocular, implantation

Human Health

R&D & Exploratory studies

IND-enabling studies

General toxicology, systemic & local

Safety pharmacology

Local effects

Non-clinical safety

Supporting services

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