Non-clinical Trials

  • BSL
  • Accelera
  • INA Research
  • Vivotecnia


BSL BIOSERVICE performs toxicology studies in close cooperation with its partner Eurofins BioPharma Product Testing Munich and has successfully established a wide range of in vivo and in vitro study designs to evaluate the safety of your drug candidates.

 

in vivo Studies

Over the past 30 years BSL BIOSERVICE gained a wide range of experience in acute, subchronic and chronic toxicity studies using various routes of administration in small and large animals, which are housed in state-of-the-art facilities with highest quality standards. We provide extensive knowledge in the testing of a variety of drug compounds in all relevant species.

 

in vitro Studies

EurofinsBioPharma Product Testing Munich GmbH has offered over the past a broad scope of in vitro tests, resulting in an extensive pool of historical data. Test systems are conducted under GLP compliance and meet the regulatory requirements for the safety testing of new drugs. For your early drug candidates we are well prepared to approach the safety assessment by applying economic screening protocols.

 

Complete IND Packages

BSL BIOSERVICE and EurofinsBioPharma Product Testing Munich provide full nonclinical development programs in support of IND and later-stage regulatory submissions for new chemical (NCE) or biological entities (NBE). On the basis of more than 20 years of experience we are guiding your project with highest flexibility and efficiency to IND and beyond.

 

Comprehensive Toxicology Studies

- Cytotoxicity, Phototoxicityin vitro

- Acute Toxicity

- Subacute, Subchronic, Chronic Toxicity

- Carcinogenicity

- Developmental &Reprodutive Toxicity (DART)

- Sensitization

- Local Tolerance Studies

  (single or repeated applications)

- Genetic Toxicology

- Safety Pharmacology

- Immunotoxicity

- Immunogenicity

- Bioanalytics

- in vitro Dermal Sensitization, Absorption & Toxicology

 


 

 

Alternative Toxicology Testing Services

EurofinsBioPharma Product Testing Munich is also offering methods for replacing the use of animals to evaluate acute systemic toxicity, skin and eye irritation and skin allergenicity but also reduce the use of animals for repeated-dose toxicity, carcinogenicity and reproductive toxicity.

 

in vivo  Pharmacology Studies: 

Knowledge of pharmacodynamic and pharmacokinetic parameters is essential for the characterization of active substances. The primary screening of compounds for pharmacological activity assists in selecting candidates for further development. There is an increasing emphasis on obtaining information about kinetics and metabolism throughout the early developmental process.

 

in vitro  Pharmacology Studies: 

In cooperation with leading research groups, EurofinsBioPharma Product Testing Munich has established several tests using different tissue culture models for quality control of pharmaceuticals. This offers you the opportunity to investigate a variety of pharmacological aspects at considerably lower costs compared to clinical trials or animal studies.

 

Drug Characterization 

- BioPrintĀ®

 

Full Profile Drug Metabolism* 

- DMPK in vitro

- ADME in vivo

 

Dermal Absorption 

- Human skin permeation

- Human skin models

 

Pharmacokinetics / Toxicokinetics

- Single / multiple application

- Bioanalytics and biometric evaluation

 

Safety Pharmacology Core Battery* 

- Cardiovascular system (Telemetry)  

- Respiratory system (Plethysmography)

- Central nervous system

- Renal system

 

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