• The application for a licence for general use (marketing application) should include a draft Summary of Product Characteristics14 for prescribers. A Patient Information Leaflet must be submitted. These should include information on the form of the product (e.g. tablet, capsule, sustained-release, liquid), its uses, dosage (adults, children, elderly where appropriate), contraindications (strong recommendation), warnings and precautions (less strong), side-effects/adverse reactions, overdose and how to treat it.
The emerging discipline of pharmacogenomics seeks to identify patients who will respond beneficially or adversely to a new drug by defining certain geno-typic profiles. Individualised dosing regimens may be evolved as a result. This tailoring of drugs to individuals is consuming huge resources from drug developers.
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