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Cipher Pharmaceuticals (TSE:CPH)
TSX:CPH
Spinosad Topical
Scabies
Phase IV
Recruiting
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
Mar 09, 2022
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Moxifloxacin 400 Mg, Tramadol Hcl
Healthy
Phase I
Completed
Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Dec 02, 2014
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Cipher Pharmaceuticals (CPH) have in its pipeline
CPH is currently developing the following drugs: Spinosad Topical, Moxifloxacin 400 Mg, Tramadol Hcl. These drug candidates are in various stages of clinical development as the company works toward FDA approval.