Drug Safety Evaluation
Creative Animodel offers a set of new drug in vivo tests and analysis that ranges from PK/PD analysis to drug safety evaluation to our global clients. In the aspect of drug safety evaluation, different detections are available to meet your special needs.
The Main Content of Drug Safety Evaluation
In the last 50 years, drug safety monitoring has developed rapidly in terms of increasing interest, broadening capacity, innovation of methods and availability of data. Safety is monitored through basic laboratory and clinical observations (e.g., heart rate, blood pressure, respiration, electrocar diogram), and being performed at frequent intervals throughout the expected duration of drug action. Clinical chemistry, hematology, and other appropriate laboratory observations are made at similar intervals. Special attention is paid to laboratory tests of organ function, especially critical target organs such as liver or kidney as well as the hematopoietic and reticuloendothelial systems, this is because toxicity is often due to loss of pharmacological selectivity by doses and concentrations increase. What’s more, special tests to monitor the activity of particular organs of interest (e.g., pulmonary function tests) may also be used to detect whether some drugs have side effect to special organs.
Drug safety evaluation, as an essential part of new drug discovery and development, we provide different assays to investigate the drug safety：
• Maximum Tolerated Dose (MTD) Study
The maximum tolerated dose (MTD) refers to the highest dose of a pharmacological treatment that causes dose-limiting adverse events in some predefined fraction of the subjects, abbreviated LD0. The purpose is to get information about the new drug’s safety. This type of analysis is also used in establishing chemical residue tolerances in foods. Maximum tolerated dose studies are also done in clinical trials. We provide different types of animal models to satisfy your research requirements.
• Dose Ranging Study
Dose ranging study gets knowledge of the relationships among dose, drug concentration in blood, and clinical response (effectiveness and undesirable effects), which is important for the safe and effective use of drugs. This study will give a comprehensive result of the new drug, including the appropriate starting dose, the adjust dosage and a maximum dose.
• Acute Toxicity Test
Acute toxicity describes the adverse effects of a substance that result either from a single exposure or from multiple exposures in a short period (usually less than 24 hours), which can provide preliminary information on the toxic nature of a new drug.
• Excellent quality management and quality assurance capacity
• Customize service for special requirements and shorter delivery time
• Both GLP standard study and Non-GLP standard assay
Creative Animodel strives to make the process of drug development easier by providing the research services, and the necessary guidance for the entire procedure. And we also have a worldwide reputation in the laboratory, what’s more, our products and services also get high reputation from our cooperated customers. Wish to cooperate with you in the near future.