Question

A pharmaceutical firm claims, "Our new drug, Teptouse, is currently used on a large number of patients to collect the evidence of therapeutic effectiveness." What stage is the new drug at for the FDA approval process?

IND filing

		Phase I of clinical testing
		Phase II of clinical testing
		Phase III of clinical testing

Answer 1

A preclinical phase is a promising agent, which involves taking advantage of the advances made in understanding a disease, pharmacology, computer science, and chemistry. Breaking down a disease process into its components can provide targeting drug development. Numerous compounds might be synthesized and tested before a promising agent emerges.before attempting a clinical trial in humans is to test the drug in living animals. The FDA requires that certain animal tests be conducted before humans are exposed to a new molecular entity. The objectives of early in vivo testing are to demonstrate the safety of the proposed medication. The results of these tests are used to support the IND application that is filed with the FDA. The IND application includes chemical and manufacturing data, animal test results, including pharmacology and safety data, the rationale for testing a new compound in humans, strategies for protection of human volunteers, and a plan for clinical testing. The FDA is satisfied with the documentation, the stage is set for phase 1 clinical trials.

Phase I of clinical testing

Focus on the safety and pharmacology of a compound.During this stage low doses of a compound are small groups of healthy volunteers are closely supervised. In cases of severe or life-threatening illnesses, volunteers with the disease may be used. Generally, 20 to 100 volunteers are enrolled in a phase 1 trial. These studies start with very low doses, which are gradually increased. About two thirds of phase 1 compounds will be found safe enough to progress to phase 2.

Phase II of clinical testing

Examine the effectiveness of a compound. To avoid unnecessarily exposing a human volunteer to a potentially harmful substance, studies are based on an analysis of the fewest volunteers needed to provide sufficient statistical power to determine efficacy. Phase 2 studies involve 100 to 300 patients who suffer from the condition the new drug is intended to treat. During phase 2 studies, researchers seek to determine the effective dose, the method of delivery and the dosing interval, as well as to reconfirm product safety. Patients in this stage are monitored carefully and assessed continuously. A substantial number of these drug trials are discontinued during phase 2 studies. Some drugs turn out to be ineffective, while others have safety problems or intolerable side effects.

Phase III of clinical testing

The final step before seeking FDA approval. During phase 3, researchers try to confirm previous findings in a larger population. These studies usually last from 2 to 10 years and involve thousands of patients across multiple sites. These studies are used to demonstrate safety and effectiveness and to determine the best dosage. The intense scrutiny a product receives before undergoing expensive and extensive phase 3 testing, approximately 10% of medications fail in phase 3 trials.

If a drug survives the clinical trials, an NDA is submitted to the FDA. An NDA contains all the preclinical and clinical information obtained during the testing phase. The application contains information on the chemical makeup and manufacturing process, pharmacology and toxicity of the compound, human pharmacokinetics, results of the clinical trials, and proposed labeling. An NDA can include experience with the medication from outside the United States as well as external studies related to the drug.