Drug development for children presents unique challenges and is highly regulated. Novel approaches, such as the use of extrapolation to address, for example, the need to avoid unethical studies, whilst supporting robust evidence generation have been developed in support of benefit/risk considerations by regulatory authorities. This is only one step in the decision-making process towards access, which in Europe also includes health technology assessment (HTA) bodies.
View Article and Find Full Text PDFAm J Med Genet B Neuropsychiatr Genet
April 2005
Several lines of evidence point to a role for dopamine in mood disorders and, in particular, in bipolar disorders. In line with a considerable amount of evidence, the dopamine D1 receptor gene (DRD1) is considered to be a good candidate gene for bipolar disorders. Several studies did not find any association between bipolar 1 patients and DRD1.
View Article and Find Full Text PDFObjective: To report the case of a patient affected by gastrointestinal stromal tumors (GIST) who developed cutaneous adverse drug reactions during treatment with imatinib and lansoprazole.
Case Summary: After 2 months of treatment with imatinib 400 mg/day, a 60-year-old white female affected by GIST developed bilateral palpebral edema with hyperemic conjunctivae and labial edema when lansoprazole 15 mg/day was introduced to treat dyspeptic symptomatology. Treatment was discontinued, and on reintroduction of both drugs, the patient developed Stevens-Johnson syndrome.