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  2. Phases of clinical research - Wikipedia

    en.wikipedia.org/wiki/Phases_of_clinical_research

    Phase III trials for dermatology may cost as low as $11 million, whereas a pain or anesthesia Phase III trial may cost as much as $53 million. [30] An analysis of Phase III pivotal trials leading to 59 drug approvals by the US Food and Drug Administration over 2015–16 showed that the median cost was $19 million, but some trials involving ...

  3. Cost of drug development - Wikipedia

    en.wikipedia.org/wiki/Cost_of_drug_development

    The Food and Drug Administration mandates a 3 phase clinical trial testing that tests for side effects and the effectiveness of the drug with a single phase clinical trial costing upwards of $100 million. [11] After a drug has passed through all three phases, the pharmaceutical company can move forward with a New Drug Application from the FDA.

  4. Clinical trial - Wikipedia

    en.wikipedia.org/wiki/Clinical_trial

    A study of clinical trials conducted in the United States from 2004 to 2012 found the average cost of Phase I trials to be between $1.4 million and $6.6 million, depending on the type of disease. Phase II trials ranged from $7 million to $20 million, and Phase III trials from $11 million to $53 million. [105]

  5. Ocugen, Inc. Announces Investigational New Drug Application ...

    lite.aol.com/tech/story/0022/20250127/9347702.htm

    NIAID, with funding from Project NextGen, will cover the full cost of the Phase 1 clinical trial, including operations and related analysis. Ocugen is providing clinical trial materials and, upon completion, will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development ...

  6. Medication costs - Wikipedia

    en.wikipedia.org/wiki/Medication_costs

    Phase 3 aims to determine the risks and benefits of a drug to its intended patient population. [21] Phase 4 trials occur after the drug is approved by the FDA and aims to continue monitoring safety and efficacy of the drug. [21] Of these phases, the phase 3 is the most costly process of drug development. [22] A single phase 3 trial can cost ...

  7. Drug development - Wikipedia

    en.wikipedia.org/wiki/Drug_development

    The average cost (2013 dollars) of each stage of clinical research was US$25 million for a Phase I safety study, $59 million for a Phase II randomized controlled efficacy study, and $255 million for a pivotal Phase III trial to demonstrate its equivalence or superiority to an existing approved drug, [20] possibly as high as $345 million. [21]