Labeling medicinal applications

A medicinal application for a photochromic dye is the use of compounds of the type 379 as near-infrared imaging agents <2005WO16934>. The compounds are used to label amyloid plaques in the brain and aid in the detection of Alzheimer s disease. 

As a result of their unique optical and electronic properties, particularly their ability to fluoresce at discrete wavelengths directly proportional to their sizes and material compositions, QDs have found use in many fields, including electronics, biology, medicine, and even cosmetics. The first attempts to modify their surface characteristics to make them water-soluble and biocompatible eventually led to their use as fluorescent labels for biomolecules in many applications (Rogach et al., 1996 Bruchez et al., 1998 Chan and Nie, 1998). 

Kubyshkin VS, Komarov IV, Afonin S, Mykhailiuk PK, Grage SL, Ulrich AS (2011) Trifluoromethyl-substituted a-amino acids as solid state 19F-NMR labels for structural studies of membrane-bound peptides. In Gouvemeur V, Miiller K (eds) Fluorine in pharmaceutical and medicinal chemistry from biophysical aspects to clinical applications. Imperial College Press (in press)... 

The Commission and the CSM also made recommendations on the introduction of many other broad safety measures. These included the Phen-acetin Prohibition Order (SI 1974/1082), presentation of medicines in relation to child safety (SI 1975/2000), and declaration of alcohol in medicinal products on their package as active ingredient where this is likely to be pharmacologically active. Other labelling issues culminated in an Order (SI 1976/1726) that set out the standard particulars that must be shown on the containers and packaging of medicinal products. Consultations on other generally applicable warnings on the labels of certain medicines to protect children and to ensure that... 

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

For a medicinal product classified for supply without a medical prescription, the proposed product label and leaflet are important elements of the application and will be closely examined for comprehensive information and effectiveness in protecting patients from any safety hazards. 

---