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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 Drug Development Paradigms and ICT : http://www10.nytimes.com/2009/11/15/business/15stream.html
aamonnz (Alexandre Monnin) Tue, 17 Nov 2009 16:42:03 -0000
New Drug Development Paradigms and ICT : http://www10.nytimes.com/2009/11/15/business/15stream.html
SIRO Clinpharm Collaborates with Mediscis, Broadens Early Phase Drug Development Expertise: MUMBAI, Ind.. http://bit.ly/sUCms #health
PRNhealth (PRNhealth) Tue, 17 Nov 2009 16:39:15 -0000
SIRO Clinpharm Collaborates with Mediscis, Broadens Early Phase Drug Development Expertise: MUMBAI, Ind.. http://bit.ly/sUCms #health
IR Imaging Could Change Drug Development: http://bit.ly/LpXF0 via @addthis
yellowcurrycake (yellowcurrycake) Tue, 17 Nov 2009 16:28:39 -0000
IR Imaging Could Change Drug Development: http://bit.ly/LpXF0 via @addthis
PPD, Janssen Enter Drug Development Pact http://bit.ly/231XWI
ContractPharma (Contract Pharma) Tue, 17 Nov 2009 15:14:43 -0000
PPD, Janssen Enter Drug Development Pact http://bit.ly/231XWI
Can smarter drug / device development curb healthcare cost inflation? We believe that's our mission. Chart of the Day http://bit.ly/Ho8Ze
trialdox (TrialDox) Tue, 17 Nov 2009 14:59:31 -0000
Can smarter drug / device development curb healthcare cost inflation? We believe that's our mission. Chart of the Day http://bit.ly/Ho8Ze
ARTES and Rhein Minapharm Continue Their Successful Product Development Collaboration http://bit.ly/BnTJR #drug
TechnologyTweet (Technology Tweets) Tue, 17 Nov 2009 14:42:03 -0000
ARTES and Rhein Minapharm Continue Their Successful Product Development Collaboration http://bit.ly/BnTJR #drug
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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