Pre-Clinical Research

Preclinical research is also named as preclinical development or non-clinical studies. In drug development it is a stage of research, performed before clinical trials can begin and during which is important feasibility, iterative testing and drug safety data are collected. Its main aim is to determine the safe dose for first in man study and should assess a products safety profile. Only one in every 5,000 compounds that enter drug discovery to the stage of preclinical development gets approved.

Each class of product should undergo preclinical research, for intensive it should undergo pharmacodynamics (what the drug does to the body), pharmacokinetics (what the body does to the drug), ADME (absorption, distribution, metabolism, excretion) and toxicology testing. Typically, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects.

 

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