Session 5: Pre-Clinical Research
20th International Conference on Clinical Nursing and Practice
In drug development, preclinical expansion, also named preclinical studies and nonclinical studies, is a stage of research that begins earlier than clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing, and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for the first-in-man study and assess a product's safety profile. Products may contain new medical devices, drugs, gene therapy solutions, and diagnostic tools.
On average, only one in every 5,000 compounds that enter drug discovery to the stage of preclinical development becomes an approved drug.
On average, only one in every 5,000 compounds that enter drug discovery to the stage of preclinical development becomes an approved drug.
Types:
Each class of product may experience different types of preclinical research. For instance, drugs may undergo pharmacodynamics, pharmacokinetics, ADME, and toxicology testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Medical devices that do not have drug attached will not undergo these additional tests and may go directly to good research laboratory practices 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 is maintainable in a living model.
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 or toxic effects on mammalian reproduction.
Submit your research on Pre-Clinical Research and be a part of our speaker panel of the upcoming 20th International Conference on Clinical Nursing and Practice (Clinical Nursing 2019) scheduled to be held in Singapore from August 19-20, 2019
Contact Us:
E: clinicalnursing@conferencesseries.org | nursingclinical@conferenceint.com
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