The draft guidance, which the US Food and Administration (FDA) is seeking comments and suggestions about, expands on what clinical pharmacology information should be included on product labels.
This section should include all information relating to clinical pharmacology and actions of the drug in humans, as well as pharmacological data based on in vitro or in vivo studies that is essential to understanding dosing or drug interaction.
Among the guidelines is the recommendation that manufacturers use graphs and tables, with variability measures included, to simplify and clarify information.
In addition to pharmacokinetic (PK) attributes the guidance suggests that graphics are worthwhile to communicate exposure- or dose-response relationships and PK/PD (pharmacodynamic) correlations.
Large sections of the document are taken up by what PK and PD information should include and how this can be presented. However, there is also a section for pharmacogenomics, which details of what genetic information should be included to assist prescribers.
The FDA recommends that manufacturers include the “effect of polymorphic variation in drug metabolising enzymes, transporters, receptors, and other proteins on PK, PD, and/or clinical responses”.
Factors in this section, as in the areas detailing PK and PD information, may also be applicable to other parts of the label, such as Drug Interactions, Warnings and Precautions, Dosage and Administration, or Contraindications. When this occurs cross-referencing should be used to avoid repetition.
The complete guidance can be found here.