Testing at this stage can take from 1 to 5 years and must provide information about the pharmaceutical composition of the drug, its safety, how the drug will be formulated and manufactured, and how it will be administered to the first human subjects. Regulatory agencies review the specific tests and documentation that are required to proceed to the next stage of development. Preclinical technology . The results of preclinical testing are used by experts in pharmaceutical methods to determine how to best formulate the drug for its intended clinical use. For example, a drug that is intended to act on the sinuses may be formulated as a time-release capsule or as a nasal spray.
Pharmacological testing determines effects of the candidate drug on the body.
Toxicology studies are conducted to ensure that any risks to humans are identified. Testing of an investigational new drug begins with submission of information about the drug and application for permission to begin administration to healthy volunteers or patients. This research can include testing of a new dosage form or new use of a drug already approved to be marketed. An IRB is an independent committee of physicians, community advocates and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. Clinical testing is usually described as consisting of Phase I, Phase II and Phase III clinical studies.