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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 ]
The Drug Development Process - http://tinyurl.com/yce7z7p
HappyAndFit (Happy And Fit) Thu, 05 Nov 2009 13:47:55 -0000
The Drug Development Process - http://tinyurl.com/yce7z7p
Creating a world-class centre for drug discovery and development http://twurl.nl/s8f2nm
PJOnline_News (PJ Online) Thu, 05 Nov 2009 13:12:27 -0000
Creating a world-class centre for drug discovery and development http://twurl.nl/s8f2nm
Incyte Reports Third Quarter 2009 Financial Results and Provides Update on Drug Development Programs (Business Wire):.. http://bit.ly/eFYlQ
proveststocks (ProVestStocks) Thu, 05 Nov 2009 12:26:02 -0000
Incyte Reports Third Quarter 2009 Financial Results and Provides Update on Drug Development Programs (Business Wire):.. http://bit.ly/eFYlQ
Microfluidic Injector of Biomolecules Into Cells Automates and Reduces Cost of A Complex Drug Development Process - http://bit.ly/2VHQEo
kenradio (Ken Rutkowski) Thu, 05 Nov 2009 12:04:49 -0000
Microfluidic Injector of Biomolecules Into Cells Automates and Reduces Cost of A Complex Drug Development Process - http://bit.ly/2VHQEo
Amylin Forms Global Alliance in Obesity Drug Development; TEDMEDâs Show Will Go On, Sequenom Sued for Civil Fra.. http://bit.ly/2GaDGR
anilbioma (Anil Thomas) Thu, 05 Nov 2009 11:32:11 -0000
Amylin Forms Global Alliance in Obesity Drug Development; TEDMED’s Show Will Go On, Sequenom Sued for Civil Fra.. http://bit.ly/2GaDGR
California Amylin Forms Global Alliance in Obesity Drug Development; TEDMEDâs ⦠â Xconomy.. http://bit.ly/3RYSma
NewsCalifornia (California) Thu, 05 Nov 2009 11:15:22 -0000
California Amylin Forms Global Alliance in Obesity Drug Development; TEDMED’s … – Xconomy.. http://bit.ly/3RYSma
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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