Related Articles Prescribing generic antiepileptic drugs: Issues and concerns for nurse practitioners. J Am Acad Nurse Pract. 2010 Jun;22(6):300-4 Authors: Barrett MW Abstract Purpose: To educate prescribing clinicians about bioequivalent standards for therapeutic equivalence of brand and generic antiepileptic durgs (AEDs) as more generic drugs come to market, and to increase awareness of practice and safety issues surrounding the use of these drugs for people with seizures. Data sources: Information was gathered from a search of the scientific literature as well as the author’s clinical experience. Conclusions: Controversy exists regarding the therapeutic equivalence of brand and generic AEDs, even when bioequivalent standards are satisfied. Generic AEDs have been associated with breakthrough seizures and adverse events that may outweigh cost savings encouraged by third-party payors. Further research is needed comparing brand to generic drugs in a rigorous manner in order to make a consensus statement regarding the safety and equivalency of generic AEDs for all patient populations. Implications for practice: Generic AEDs may be safely prescribed in certain situations if clinicians are aware of ethical, legal, and practice issues surrounding their use. Sufficient time should be spent educating patients, caregivers, and pharmacists about implications of a switch made without the knowledge of the patient and/or prescriber. PMID: 20536627 [PubMed - in process]
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Prescribing generic antiepileptic drugs: Issues and concerns for nurse…
Related Articles How to extrapolate a withdrawal time from an EHSLC published detection time: A Monte Carlo simulation appraisal. Equine Vet J. 2010 Apr;42(3):248-54 Authors: Toutain PL Reason for performing study: For legitimate medications, veterinarians must advise the owners or trainers of horses on appropriate withholding times after a treatment, to avoid the risk of incurring a positive drug test. Objective: To explore the safety span to select that a veterinarian may extrapolate a tailored withdrawal time (WT) from a generic detection time (DT) as published by the European Horserace Scientific Liaison Committee (EHSLC). Methods: Using Monte Carlo simulations, it was shown that for a low variability of pharmacokinetic parameters (CV = 20%), an uncertainty span of about 40% may be selected to transform a mean DT into a WT (i.e. WT = 1.4 DT), which covers 90% of the horse population. In contrast for a highly variable drug (CV = 40%), an uncertainty factor of about 2.1-2.2 needs to be selected, i.e. a WT that is twice the DT. Results: The relative impact of the different factors of variability on the final WT was documented by a so-called sensitivity analysis. It was shown that the parameters that have the greatest influence on the value of a DT are those that control the terminal half-life of the drug disposition. In contrast, parameters controlling the level of urine (or plasma) concentrations (i.e. the actual administered dose, the urine-to-plasma ratio and the bioavailability) collectively have a minimal influence on the DT. Conclusions and potential relevance: In practice, this means that the main sources of uncertainty are of biological origin and cannot be reduced by any managerial options. The influence of the number of experimental horses that are used by EHSLC to establish a DT was shown that with the standard EHLSC protocol of 6 horses, half of the trials lead to a proposed DT that is equal to or higher than the population 90(th) percentile. Increasing the number of investigated horses to 8 and 10 would increase this last probability to 85 and 90%, respectively. PMID: 20486982 [PubMed - in process]
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How to extrapolate a withdrawal time from an EHSLC published detection…
