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*

In search of suitable long wave ultraviolet light source which is not available in Korea for photopatch tests and for the treatment of vitiligo and psoriasis. We picked high pressure mercury lamp used for out-door illumination for evaluation. On spectrophotometric examinatio., it is disclosed that the lamp emitted enough long wave ultraviolet rays for our purpose. It requires 6 minutes for photopatch tests at 50 cm for 200 watt bulb. It is recommanded that the commercially available cheap out door illumination lamp should be used for dermatological parposes until equivalent medical equipment is available. The construction and principle of mercury vapor lamp is reviewed.
Korea ; Lighting* ; Psoriasis ; Ultraviolet Rays ; Vitiligo

In previous paper we reported on the radiation spectrum of commercially ava ilable out-door illumination lamp and suggested the use of this lamp as long ultraviolet light source until such time we have adquate medical equipments availahle. We tried to dectermine the erythema dose of above lamps in conjunction with topical psoralen and tar. The skin lamp distance was kept 50cm. The test sites were the backs of 30 young volunters. 200 watt bulbs were used. l. 30 minutes topical application of 0.25% Meladoxen solution required 2 to 6 minutes of exposure to inducs erythema in 48 hours. 2. 6 hours of topical tar application needed 2 to 8 minutes of exposure. 3. With 0.25% Meladoxen solution; 30 minutes of topical application produced more phototoxic effect tnan 2 or 24 hours. 4. With 5% Tar ointment; the longer the duration of topical application the stronger was the phototoxic effect. But topical application time exceeding 6 hours failed to increase phototoxic effect furtber. 5. With 0.3% Meladoxen cream the thicker the applied cream the stronger was the phototoxic effect up to 25mg per cm, over which phototoxic effect decreased, probably due to the screening effect of the cream, It is concluded that in the photochemical treatment of vitiligo and psoriasis psoralen sould be applied for 80 minutes, the tar for 6 hours or ovemight before irradiating the lesions with long wave ultraviolet rays. In this way the time required for each session of photochemical treatment of psoriasis or vitiligo will be greatly reduced while obtaining maximum effect. This is more significant in the view of long term treatmant required for the management of these embarrasing dermatoses.
Erythema ; Ficusin ; Lighting* ; Mass Screening ; Psoriasis ; Skin ; Skin Diseases ; Ultraviolet Rays ; Vitiligo

OBJECTIVE: to determine whether ovarian steroids directly regulate FSH release and B subunit synthesis at the pituitary level METHODS: In vitro study. After applying ovarian steroids in cultured rat anterior pituitary cells, we evaluate the amount of relesed FSH and FSH B subunit using dot-blot hybridization. RESULTS: Estradiol alone or GnRH-induced did not modulate FSH release and B ubunit synthesis. Although progesterone alone did not alter FSH release, GnRH-induced FSH release was significantly augmented by the treatment of progesterone. Progesterone alone stimulated FSH B mRNA level. Significant increase in FSH B mRNA level was also observed by the combined treatment of progesterone and GnRH. The effects of progesterone on GnRH-induced FSH release was significantly reduced by the treatment of progesterone antagonist, RU 486. The treatment with progesterone antagonist, RU 486 also abolished progesterone-induced FSH B subunit mRNA biosynthesis. CONCLUSION: From these results, it is, therefore, concluded that estradiol does not seem to be a major regulator for FSH synthesis but progesterone may exert its action at the pituitary level for the synthesis and release of FSH.
Animals ; Estradiol ; Estrogens ; Gonadotropin-Releasing Hormone ; Mifepristone ; Progesterone ; Rats* ; RNA, Messenger ; Steroids

No abstract available.
Child* ; Heart Septal Defects, Ventricular* ; Humans

No abstract available.
Education, Medical* ; Humans ; Students, Medical*

Bleoxycin is known to have good therapeutic effect on verrucae, which has been used for varioua malignant turnors for its antimitatic effect RecentIy Kim & Kim, reported an exceIIent treatment method. of verrucae with Bleomycin using needle free. They poetulated that the excellent effcts were achievei thraugh infiltration of the ekin, in.cluding the affected epidermis, with Bleomycin which is not possible with other rnethods, It is therefore interesting to know the effects of Dermajet instilled Bleomycin an normal ekin. We selected guinea pigs for thia experirnent. Five albino guixim pigs, weighting about 500 Gm, were ueed. Bleomycin water ohxtion, 0.25mg/ml, 0.06ml for each chet was injected utilizing Dermojet on the back of a guinea pig after clipping. The injected sites and the contralateral sites were tiopsied a,fter vaxying length of time and histologia examinationa were made. The experiment was eoarranged that the biopsies for different experiment aitea celd be done on oxeittirnig. Fix hours after the bleomycin injection, the epidermis becase shrunk and t@4e upper dermie showed aligbt inflammatory infiltration. After 10 hours. and also after 24 houra, a auperficial ulceration and necrosis were noted and the dermal infiltration became progressively severer. After 2 days epithelization, had started and. the necrotic debris began to drop off. After 4 daya the epithelization was camplete. These findings were in sorne part similar to the findings observed in humans by Kirn and Kim in the treatment af verruca but th time sequenc was far faster in guinea pigs.
Animals ; Biopsy ; Bleomycin* ; Epidermis ; Guinea Pigs* ; Guinea* ; Humans ; Necrosis ; Needles ; Skin* ; Swine ; Ulcer ; Warts ; Water

Orthopaedic wire has been used widely as a good internal fixator in cases of fracture, the ligament reconstruction, and for the stabilization of cervical spine. But if it is used inappropriately, a wire can be easy to fail by elongation, untwisting, or breakage. Among them, the most common failure of wire is breakage. To clarify the mechanism and the causes of wire failure, the authors analysed serial roentgenograms and scanning electronmicroscopic findings of broken wire in total 13 cases, which were experienced at the department of orthopaedic surgery, St. Mary's Hospital, Catholic University Medical College From January 1981 to December 1987. The results obtained were as follows :1. The mechanism of wire failure were classified into the 4 types ; minor continual flexing motion in 6 cases, repeated minor back and forth torsion in 1 case, tension failure in 2 cases and combined type in 4 cass. 2. The causes of wire failure were in appropriate use and inadequte application, a lack of s ufficient mechanical strength, micromotion due to inadequate postoperative imm obilization, early mobilization before tissue healing as well as certain injuries to the wire during handling in operation.
Early Ambulation ; Fatigue ; Internal Fixators ; Ligaments ; Spine

No abstract available.
Arm* ; Free Tissue Flaps*

No abstract available.
Stomach Neoplasms* ; Tuberculosis, Pleural*