Breaking News on Pharmaceutical=20 Technology
FDA pushes graphics on product labels
By Nick Taylor, 04-Mar-2009
Related topics:
Use of graphs and tables depicting pharmacokinetic attributes is = among the=20 recommendations made in the FDA=E2=80=99s latest guidance on clinical = pharmacology=20 labelling of prescription drugs.
The draft guidance, which the US Food and Administration (FDA) is =
seeking=20
comments and suggestions about, expands on what
This section should include all information relating to clinical = pharmacology=20 and actions of the drug in humans, as well as pharmacological data based = on=20 in vitro or in vivo studies that is essential to = understanding=20 dosing or drug interaction.
Among the guidelines is the recommendation that manufacturers use = graphs and=20 tables, with variability measures included, to simplify and clarify = information.=20
In addition to pharmacokinetic (PK) attributes the guidance suggests = that=20 graphics are worthwhile to communicate exposure- or dose-response = relationships=20 and PK/PD (pharmacodynamic) correlations.
Large sections of the document are taken up by what PK and PD = information=20 should include and how this can be presented. However, there is also a = section=20 for pharmacogenomics, which details of what genetic information should = be=20 included to assist prescribers.
The
Factors in this section, as in the areas detailing PK and PD = information, may=20 also be applicable to other parts of the label, such as Drug = Interactions,=20 Warnings and Precautions, Dosage and Administration, or=20 Contraindications. When this occurs cross-referencing should be = used to=20 avoid repetition.
The complete guidance can be found
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