General Toxicity

General toxicity testing is a critical component of drug discovery and early preclinical drug development. Early evaluation of the safety or general toxicity of a particular molecule or set of compounds provides valuable information about a compound, compound formulation or route of administration. This information not only supports decision making about the further development of a compound but also provides important guidelines for the design of more extensive efficacy studies in animal disease models. If time is of importance, toxicity parameters may also be incorporated into efficacy studies.

Cephrim Biosciences offers preclinical toxicity testing for the evaluation of drug candidates and in support of pharmacokinetic and efficacy study planning.

Our services include:

  • Acute toxicity studies
  • Subchronic or chronic, multiple or repeat dosing studies (e.g. 14 days or 56 days)
  • Lethal dose determination (LD10, LD50)
  • Single maximal tolerated dose determination (MTD)
  • Toxicity screening: acute LD, intrinsic toxicity, organ gross examination, hematology and clinical chemistry, pathology, preliminary toxicokinetics
  • Evaluation of immunogenicity

Toxicology studies the following procedures:

  • Timed dosing and sampling
  • Necropsy services include removal, weights, and preservation of designated organs or tissues for further analysis
  • Plasma and/or serum collection
  • Histology and pathology

The core set of our safety studies evaluates the effects of compounds on vital functions of the three major physiological systems: central nervous, cardiovascular, and respiratory systems. Supplemental studies for other organs can be added to each study when needed.

Routine studies:

  • Central Nervous System
  • Modified Irwin test and Functional Observation Battery (FOB) in rodents
  • Cardiovascular System
  • Effects on blood pressure, heart rate, and ECG (electrocardiogram)
  • Respiratory System
  • Effects on respiratory function

Supplemental Studies:

  • Renal function
  • Hematology and blood chemistry