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Drug Development or Preclinical Development is defined in many pharmaceutical companies as the process of taking a new chemical lead through the stages necessary to allow it to be tested in human clinical trials, although a broader definition would encompass the entire process of drug discovery and clinical testing of novel drug candidates.
Novel chemical entities (NCEs) are compounds which emerge from the process of drug discovery. These will have promising activity against a particular biological target thought to be important in disease, however little will be known about the safety, toxicity, pharmacokinetics and metabolism of this NCE in man. It is the function of drug development to assess all of these parameters prior to human clinical trials. A further major objective of drug development is to make a recommendation of the dose and schedule to be used the first time an NCE is used in a human clinical trial ("First-in-Man", FIM).
In addition, drug development is required to establish the physicochemical properties of the NCE: its chemical makeup, stability, solubility. The process by which the chemical is made will be optimised so that from being made at the bench on a milligram scale by a synthetic chemist, it can be manufactured on the kilogram and then on the ton scale. It will be further examined for its suitability to be made into capsules, tablets or intravenous formulations. Together these processes are known in preclinical development as CMC: Chemistry, Manufacturing and Control.
More on [ Drug development ]
New Software from SRI Speeds Development of Genome-Scale Models for Drug and ...: 24, 2012 -- /PRNewswire/ -- SR... http://t.co/rGyn0zac
rancerichman (rance.richman) Tue, 24 Jan 2012 23:14:00 -0000
New Software from SRI Speeds Development of Genome-Scale Models for Drug and ...: 24, 2012 -- /PRNewswire/ -- SR... http://t.co/rGyn0zac
New Software from SRI Speeds Development of Genome-Scale Models for Drug and ...: 24, 2012 -- /PRNewswire/ -- SR... http://t.co/v5rbBfEc
SijessRa6 (Sijess Ra) Tue, 24 Jan 2012 23:13:54 -0000
New Software from SRI Speeds Development of Genome-Scale Models for Drug and ...: 24, 2012 -- /PRNewswire/ -- SR... http://t.co/v5rbBfEc
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Abigail Alliance for Better Access to Developmental Drugs - Dedicated to helping develop wider access to developmental cancer drugs and other drugs.
Alliance for Cancer Gene Therapy - Raises and distributes funds for scientific research of all types of cancer, utilizing cells and genes as medicines.
Meta Description: [ The alliance for Cancer Gene Therapy is the only public charity in the nation dedicated exclusively to investing in research into cancer gene therapies. The letters A[Adenine] C[Cytosine] G[Guanine] and T[Thymine] makes up the genetic code of all genes. ]
CancerActionNow - Patient advocacy for cancer drug development, compassionate use programs and expanded early access to promising therapies.
Meta Description: [ The Marti Nelson Cancer Foundation/CancerActionNow.org works to make effective and safe cancer treatments available to cancer patients. We help cancer patients identify treatment options if the standard treatment for their cancer has not helped them. ]
National Foundation for Cancer Research - Resource for research, related information and news, prevention and detection.
Meta Description: [ National Foundation for Cancer Research ]
Syncure Cancer Research Foundation - Charitable organization aimed at developing treatments for cancer based on the research of new compounds.
The Cancer Federation - Non-profit which supports cancer immunology research. Includes a history, contact information and space for post cancer memorials.
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