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A Previous Human Experience (PHE) is a summary of previous human experience known to the applicant, if any, with the investigational drug. It is a component of an IND application for clinical investigations to the US FDA to get approval for starting clinical trials and shipping unapproved drugs across state lines. Its purpose is to provide evidence from previous human experience. If no previous human experience exists, this should be stated in this section of the IND application.
There is no specific format for describing previous human experience with an investigational drug in an IND application. If there is no previous human experience, this should be stated.
The PHE includes detailed information about experience relevant to the safety of the proposed investigation or to the investigation’s rationale. All relevant information to the drug’s safety and effectiveness for the proposed investigational use(s) should be provided. It lists other countries where the drug has been marketed or withdrawn from marketing for reasons potentially related to safety or effectiveness.
The development of this document requires input from multiple functions. For initial IND applications, the parallel development of several other IND components might be a challenging factor.
The Medical Writer can fulfill an important role in the document development process (eg, write sections, circulate for review, implement comments), often in combination with the General investigational Plan and the Investigator’s Brochure for an initial IND application.