Toxicology Studies in Drug Development

Application of Toxicology Studies in Drug Development

1. Preclinical safety evaluation of new drugs

2. Pre-clinical evaluation procedure of drug toxicity

3. Safety of medical nanomaterials

4. Application of drug toxicology in clinical pharmacy

5. Application materials for toxicology studies

Pharmacology and Toxicology Studies

Medicilon has a professional team and practical experience in drug safety evaluation, which can provide high-quality data and a fast turnaround period to support various drug safety evaluation studies. Toxicological studies can be performed in accordance with non-GLP or GLP standards. Our research platform has been rated as a Shanghai R&D public service platform.

Medicilon toxicology and pharmacology studies:

Single dose toxicity test (rodent and non-rodent)
Repeated dose toxicity test (rodent and non-rodent)
Safety pharmacological tests: central nervous system research, cardiovascular system (canine and monkey telemetry and non-telemetry technology), respiratory system
Genotoxicity test
Reproductive toxicity test [Fertility and early embryo development toxicity test (reproduction stage I), embryo-fetal development toxicity test (reproduction stage II)]
Immunogenicity test
Toxicokinetics
Local toxicity test (hemolysis, allergy, irritation test)
Service objects: pharmaceutical R&D institutions, pharmaceutical factories, pharmaceutical companies, hospitals, schools, etc.

Preclinical Toxicology Studies

Common toxicology research test items:

Clinical pathological testing items mainly include the following:

• Hematology

White blood cell count (total white blood cell count and five counts of white blood cells), red blood cell count, hemoglobin, hematocrit, average red blood cell hemoglobin content, average red blood cell volume, average red blood cell hemoglobin concentration, reticulocyte absolute value and percentage, platelet count, blood cell morphology

• Urine analysis

Microscopic examination of volume, specific gravity, pH, color and appearance, protein, glucose, bilirubin, ketone bodies, occult blood, urobilinogen, nitrite, leukocytes, urine sediment

• Coagulation

Prothrombin, activated partial thromboplastin time, thrombin time, fibrinogen

• Clinical biochemistry

Alkaline phosphatase, total bilirubin, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transferase, urea nitrogen, creatinine, total protein , Albumin, globulin, glucose, total cholesterol, triglycerides, electrolytes (potassium, sodium, chloride), calcium, phosphorus, creatine kinase, high density lipoprotein cholesterol, low density lipoprotein, cholesterol, bicarbonate ( carbon dioxide)

Toxicology studies

Animal facilities and capabilities

Medicilon is fully certified by AAALAC and is a CLP GLP laboratory. The non-clinical safety evaluation of the drug meets the GLP requirements of CFDA, USFDA and OECD. Have the animal facilities and capabilities you need:

Total facility area of 8,000 square meters

Functional area 2,000 square meters

Dog animal room 1,500 square meters: can accommodate 400

Non-human primate room 1,500 square meters: can accommodate up to 400

Rodent barrier system animal house 3,000 square meters: SPF area can accommodate up to 8000; non-SPF area can accommodate 500

Facilities are designed and operated in accordance with international and domestic standards

contact us

Email: marketing@medicilon.com

Phone: 86-021-58591500

Website: www.medicilon.com

The above is about new drug toxicology studies, pre-clinical toxicology studies, if you need service, please contact us.

Related Articles:

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General Toxicology Study Service

GLP Toxicology Studies

Pharmacokinetic test / toxicokinetic test

Preclinical studies and clinical trials of drugs

Toxicokinetic Studies in Animals