Editing Preclinical development (section)

== Types ==
Each class of product may undergo different types of preclinical research.  For instance, drugs may undergo [[Pharmacodynamics|pharmacodynamics (what the drug does to the body)]] (PD), [[Pharmacokinetics|pharmacokinetics (what the body does to the drug)]] (PK), [[ADME]], and [[toxicology testing]].  This data allows researchers to [[Allometry|allometrically]] estimate a safe starting dose of the drug for [[clinical trial]]s in humans.  Medical devices that do not have drug attached will not undergo these additional tests and may go directly to [[good laboratory practice]]s (GLP) testing for safety of the device and its components. Some medical devices will also undergo biocompatibility testing which helps to show whether a component of the device or all components are sustainable in a living model. Most preclinical studies must adhere to GLPs in [[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH]] Guidelines to be acceptable for submission to regulatory agencies such as the [[Food & Drug Administration]] in the United States.

Typically, both ''[[in vitro]]'' and ''[[in vivo]]'' tests will be performed.  Studies of drug toxicity include which organs are targeted by that drug, as well as if there are any long-term [[carcinogenic]] effects or toxic effects causing illness.