Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 82

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 82
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 based upon the type, complexity and novelty of the product or disease.

Preclinical
tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics
and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements,
including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information,
including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical
tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted. A 30-day waiting period
after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented
on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin. Clinical trials involve the administration
of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials
must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice, or GCP, an international
standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors;
as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness
criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the
FDA as part of the IND.

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Clinical
trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase
I, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics,
pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness. Phase II usually
involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance
and optimum dosage, and to identify common adverse effects and safety risks. If a drug demonstrates evidence of effectiveness and an
acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to obtain the additional information about clinical
efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to
evaluate the overall