Phases of drug development // Drug Repurposing

Phases of drug development

Clincal Researcher Looking Through a Microscope
  • Basic Research/Drug Development

New potential * are discovered at this stage. At this point, the investigators test their ideas at the laboratory bench and in machines or “test tubes, ” but the experiments can also involve cells and specially-bred animals. The potential treatments can be made from all sorts of materials, including natural or synthetic chemical compounds and bioengineered or biological materials, like antibodies. Some are “repurposed, ” meaning that they have been approved for treatment of one or more disease(s) and are being tested for their potential to treat another disease.

Much of this basic research is done to determine more details about the disease studied and what proteins, genes or system processes contribute to the development and/or progression of the disease. These clues to potential avenues for treatment are essential to be able to design drugs for further testing. The clues can also help with designing large “high-throughput” drug screening techniques.

Doctors Reviewing Clinical Trial InformationOnly potential treatments that have the best evidence for potential safety and effectiveness in animals and humans move forward to . The list of treatments is whittled down to much smaller numbers as some make it past the tests and others do not.

  • Pre-Clinical/Translational Research

The potential * identified to have therapeutic potential in the stage are then tested in animals for their ability to be delivered to the target organ(s) and tissue(s), to determine how well they are cleared from the system, and to determine their toxicity, safety, and effectiveness. Many potential treatments that do not pass certain tests may be “dropped” at this stage, since they may seem too risky for further development for use in patients.

Normally, one of the Pre-Clinical tests must involve a type of animal that has a condition similar to one or more symptoms held by human patients of the particular disease for which a treatment is being pursued.

Translational Research involves studies that give evidence that the effectiveness shown for a particular treatment has a good chance that similar results could occur in humans. Essentially, the research must show that the results can “translate” into helping patients who have the disease or condition.

Many promising treatments are never tested in clinical trials due to lack of funding or other business difficulties. In many cases, further financial support or partnerships are needed to help “bridge the gap” across the “”** to begin Phase 1 Clinical Trials.

Microscope Doctors Reviewing a Medical Scan

You might also like

$6 million ImClone stock sale routine

by miredincontroversy

Until a few weeks ago, Dr. John Mendelsohn's name surfaced mostly in prominent medical circles.
Now the M.D. Anderson Cancer Center president is the subject of scrutiny as a board member for two companies mired in controversy: Enron Corp. of Houston and ImClone Systems based in New York City.
Both companies are being investigated by the House Energy and Commerce Committee, and the latter is accused in shareholder lawsuits of misleading investors about the drug's potential for approval.
The 65-year-old Mendelsohn maintains he has done nothing wrong. He admits selling 90,000 shares of ImClone for $6 million at $70 each in late October, a month before the stock tanked

US Created Aids to kills blacks

by aids

Trafficant to Investigate AIDS Production Program
by MIKE MCNAIR
(Washington, D.C.)Apparently Congressman Trafficant is not too involved in his own defense to deal with other issues.
The Congressman is calling for an investigation into the Special Virus Cancer Program, as a result of the research done
by Dr. Boyd Graves to uncover the complicity of the U.S. Government in the creation of the AIDS virus.
'The Congressman has agreed to ask for an investigation by the GAO or
the Congressional Committee on Investigations,' said Trafficant's
Regional Director Anthony Traficanti

Chapman and Hall/CRC Theory of Drug Development (Chapman & Hall/CRC Biostatistics Series)
Book (Chapman and Hall/CRC)

Novella Clinical Names Dr. Lynne Bui Senior Medical Director of Oncology ..  — PharmiWeb.com
Dr. Bui is a board certified hematologist/oncologist with more than nine years' industry experience in all phases of drug development for solid tumors and hematologic malignancies.

Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development: A Focus on Early Phase Clinical Studies
Book (Springer)
Author Clinical Pharmacology of Cannabinoids in Early Phase Drug Development
Book (Author)
CRC Press Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
Book (CRC Press)
Wiley Physicochemical and Biomimetic Properties in Drug Discovery: Chromatographic Techniques for Lead Optimization
Book (Wiley)