10 research outputs found

    J9192

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    ABSTRACT: The transformations of tristearin were examined by modulated temperature differential scanning calorimetry (MTDSC) in order to examine the utility of this technique. Tristearin has been used as a model polymorphic system, showing metastable phases and complicated transformation routes occuring at relatively slow rates. The β′-forms generated by thermal treatment under modulation do not differ significantly from those generated by the corresponding treatment without modulation. While the total heat flow thermograms are similar, the deconvoluted reversing component shows that annealing, especially at 63°C, has a significant effect on the crystal size and perfection of the solid phases formed. MTDSC also enables the melting of β′ to be separated from the simultaneous crystallization of the β form as evidenced in the c p component. Quantitative interpretations about such systems cannot be drawn from MTDSC at this point in time. Paper no. J9192 in JAOCS 76, 507-510 (April 1999)

    Congenital malformations

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    Although we tend to be reluctant in exposing mother and child to drugs, treatment with medicinal products during pregnancy cannot always be avoided. In the past decades several safety issues occurred that highlighted the need for special attention for the use of medicinal products during pregnancy. Whether or not a drug causes a potential teratogenic effect depends on several factors. Moreover, effects may be visible at birth, but may also become apparent later in life, among which developmental disorders. Before marketing of a drug the information about the safety in pregnancy is sparse and mainly limited to animal studies and scarce observational data. Clinical trials carried out before marketing, rarely include pregnant women, except when the product is specifically intended to be used in pregnancy. For the most part, effects of drug use during pregnancy can only be identified after marketing of the drug and when used by pregnant women. The optimal method for evaluating the risk of exposure to drugs in pregnancy strongly depends on the stage of drug development. Preapproval data on risks during pregnancy is limited and most information in this phase comes from embryo-fetal toxicity studies in animals. In the post-marketing phase observational studies are preferred. Next to the clinical presentation, epidemiology, and mechanisms of congenital malformations, the most prominent study types used in the premarketing phase; case reports and case series, cohort- and case control studies, will be discussed. Subsequently, possible ways to study the safety of drugs after marketing will be highlighted as well as current regulations for monitoring drug safety during pregnancy will be addressed

    Medicines associated with folate–homocysteine–methionine pathway disruption

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    The Placental Barrier: the Gate and the Fate in Drug Distribution

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    Challenges and Future Prospects for the Delivery of Biologics: Oral Mucosal, Pulmonary, and Transdermal Routes

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