Korean Guideline for Iron Chelation Therapy in Transfusion-Induced Iron Overload

Many Korean patients with transfusion-induced iron overload experience serious clinical sequelae, including organ damage, and require lifelong chelation therapy. However, due to a lack of compliance and/or unavailability of an appropriate chelator, most patients have not been treated effectively. Deferasirox (DFX), a once-daily oral iron chelator for both adult and pediatric patients with transfusion-induced iron overload, is now available in Korea. The effectiveness of deferasirox in reducing or maintaining body iron has been demonstrated in many studies of patients with a variety of transfusion-induced anemias such as myelodysplastic syndromes, aplastic anemia, and other chronic anemias. The recommended initial daily dose of DFX is 20 mg/kg body weight, taken on an empty stomach at least 30 min before food and serum ferritin levels should be maintained below 1000 ng/mL. To optimize the management of transfusion-induced iron overload, the Korean Society of Hematology Aplastic Anemia Working Party (KSHAAWP) reviewed the general consensus on iron overload and the Korean data on the clinical benefits of iron chelation therapy, and developed a Korean guideline for the treatment of iron overload.

Korean Guideline Development for the Evaluation of Permanent Impairment of the Spine: Proposal by the Korean Academy of Medical Sciences Committee

The criteria for the evaluation of spinal impairment are diverse, complex, and have no standardized form. This makes it difficult and somewhat troublesome to accurately evaluate spinal impairment patients. A standardized guideline was studied for the evaluation of spinal impairment, based on the American Medical Association (AMA) Guides and the McBride method. This guideline proposal was developed by specialty medical societies under the Korean Academy of Medical Sciences. In this study, the grades of impairment were assessed by dividing patients into three different categories: spinal cord impairment, spinal injury impairment and spinal disorder impairment. The affected regions of the spine are divided into three: the cervical region, the thoracic region, and the lumbosacral region. The grade of impairment was differentially evaluated according to the affected region. The restricted range of motion was excluded in the evaluation spinal impairment because of low objectivity. Even though the new Korean guideline for the evaluation of spinal impairment has been proposed, it should be continuously supplemented and revised.

Bioequivalence Test and Its Significance

Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar experimental conditions in either a single dose or multiple doses in an appropriately designed study. If a drug is to be bioequivalent to the reference drug, the confidence interval for both pharmacokinetic parameters, AUC(area under the plasma concentration-time curve) and Cmax(maximal plasma concentration), must be entirely within the 80% to 125% of those of the reference drug. Underlying the concept of bioequivalence is the thesis that, if a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted for that drug product. The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent. In this paper the general concept and the practical significance of the bioequivalence is described. The recently revised Korean guideline for bioequivalence test is also discussed.