E-Clinical

Drug development - Pre-clinical 1 The information gathered from this pre- clinical testing, as well as information on CMC, and is submitted to regulatory authorities (in the US, to the FDA), as an Investigational New Drug application or IND. If the IND is approved, development moves to the clinical phase.

Phases of clinical research - Pre-clinical studies 1 Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical development|pre-clinical studies. These involve in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug.

Pre-clinical development 1 In drug development, 'pre-clinical development', also named 'preclinical studies' and 'nonclinical studies', is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data is collected.

Pre-clinical development 1 The main goals of pre-clinical studies are to determine a product's ultimate safety profile. Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc.

Pre-clinical development - Types of preclinical research 1 Most pre-clinical 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.

Pre-clinical development - No observable effect levels 1 Based on pre-clinical trials, No Observable Adverse Effect Levels (NOAEL) on drugs are established, which are used to determine initial phase 1 clinical trial dosage levels on a mass Active ingredient|API per mass patient basis. Generally a 1/100 uncertainty factor or safety margin is included to account for interspecies (1/10) and inter-individual (1/10) differences.

Medical education in Jordan - The Pre-Clinical Stage 1 The integrated system pre-clinical phase requires that the students are assessed at the end of each course by a series of multiple-choice examinations

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