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.
Drug Substitution ; Humans ; Molar ; Plasma ; Therapeutic Equivalency*

No abstract available.
Emergencies* ; Emergency Medicine* ; Korea*

No abstract available.
Rhinitis*

No abstract available.
Ethics*

No abstract available.

It has been reported that overexpression of HER-2/neu occurs in one third of breast and ovarian cancers and that overexpression is associated with poor prognosis. A polyclonal antibedy against HER-2/ neu oncoprotein was used to assess immunohistachemically the level of HER-2/neu expression in normal and malignant endometrial carcinoma. In 8 normal endometrial samples light to moderate(0- +2) staining for HER-2/neu was seen in the giands, and there was no variation in intensity of staining during the menstrual cycle, Among 15 endometrial adenocarcinomas. three(20%) were found to have heavier staiaing (+3) for HER-2/neu than was seen in normal endometrium. High expression of HER-2/neu was found in 50%(1/2) of patients with metastatic disease(stages III or more) compared with 15%(2/13) of patients with disease confined to the uterus(stage I). Survival of the 3 patients with high HER-2/neu expression was significantly worse than that of the 1.2 patients with normal HER-2/neu expression. (Median survival: 49. I vs 28. 7 months (p=0.0348)) Further studies are needed to determine the significance of HER-2/ neu overexpression in endometrial cancer.
Adenocarcinoma ; Breast ; Endometrial Neoplasms* ; Endometrium ; Female ; Humans ; Menstrual Cycle ; Ovarian Neoplasms ; Prognosis

No abstract available.
Epidemiology* ; Hallucinogens* ; Narcotics*

The thyroid nodule is a very common thyroid disease in adults, with an increasing incidence. Cancers are found in 10~14% of patients presenting with palpable thyroid nodules. As FNA is the single best test for evaluation of thyroid nodules, FNA should be the first test in patients with a thyroid nodule 1cm or larger. According to the FNA findings, thyroid nodules are usually classified into three categories: malignant, benign, and suspicious/indeterminate lesions. Malignant nodules should be treated by surgery, while benign nodules can be followed without any medical treatment or suppressed by L-T4 treatment. Patients with suspicious/indeterminate nodules, are malignant in 10% to 20% of cases, should be advised to undergo surgery.
Adult ; Humans ; Incidence ; Thyroid Diseases ; Thyroid Gland* ; Thyroid Nodule*

Antibiotics are prescribed to prevent infection and to treat established or presumptive infections. In choosing the appropriate antibiotics, a number of factors must be considered. First, the identity of the infecting organism must be known. Second, the information about the antibiotic susceptibility of the infecting organism must be as accurate as possible. Finally, host factors must be taken into consideration. The pharmacokinetics and pharmacodynamics of antibiotics in children are different from those in adults and are important host factors. The antibiotics may be classified into several groups : the beta-lactams (i.e., penicillins, cephalosporins, carbacephems, and monobactam), glycopeptides (i.e., vancomycin), aminoglycosides, macrolides, and quinolones. This article describes the clinical application of selected antibiotics to infectious diseases with newly available agents in children. The development of new oral agents prescribed as once or twice per day achieves enhanced compliance. These include cefprozil, cefpodoxime, loracarbef, azithromycin, clarithromycin, and fluoroquinolones. Meropenem is also a newly available carbacephem approved for use in children. Antibiotics available but not approved for use in children are imipenem-ci-lastatin, aztreonam, quinolones, and several cephalosporins including "fourth"-generation such as cefipime. Recently the use of once-daily dosing of aminoglycosides has been evaluated in pediatric populations, which appears to be safe and effective, although further studise are warranted. The emergence of antibiotic-resistant bacteria has generally been correlated with the rise of specific antibiotic use in clinical practice. Although the development of resistance may be inevitable, the rate at which it develops may be diminished by the rational use of antibiotics.
Adult ; Aminoglycosides ; Anti-Bacterial Agents ; Azithromycin ; Aztreonam ; Bacteria ; beta-Lactams ; Cephalosporins ; Child ; Clarithromycin ; Communicable Diseases ; Compliance ; Fluoroquinolones ; Glycopeptides ; Humans ; Macrolides ; Penicillins ; Pharmacokinetics ; Quinolones

No abstract available.
Emergencies*