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Quantum Pharmaceuticals in drug discovery

5. Pre-clinical technology. During the pre-clinical development of a drug, a laboratory tests the effect of the investigational drug on living organisms (in vivo) and on cells in a test tube (in vitro).

6. Pharmaceuticals / Pharmacology & Toxicology. The results of pre-clinical testing are used by pharmaceutical experts to determine how to best formulate the drug (in what form) for its intended clinical use. Pharmacological testing determines the effects of the candidate drug on the body. Toxicology studies are conducted to ensure that any risks to humans are identified.

7a. Phase I Clinical Studies. Phase I studies are designed to verify the safety and tolerability of the candidate drug in humans and typically take 6 to 9 months. This is the first round of testing conducted in humans. Typically, 20 to 100 healthy volunteers take the investigational drug. Testing includes observation of how the drug acts in the body -- how it is absorbed, distributed, metabolized and excreted.

7b. Phase II Clinical Studies. Phase II studies are designed to determine the effectiveness of the drug and further study its safety for humans. This phase of development generally takes from 6 months up to 3 years. Testing is conducted on up to several hundred patients suffering from the target disease. This testing also determines the minimum and maximum effective dose.

7c. Phase III Clinical Studies. Phase III studies provide expanded testing of the effectiveness and safety of an investigational drug. This phase of development usually requires 1 to 4 years of testing and is conducted on several hundred up to thousands of volunteer patients.

After the above mentioned steps, the drug is approved and certified by the Food and Drug Administration (FDA) in the U.S. or by the applicable regulatory authorities in other countries.