• Analytical Science and Technology
• /
• v.35 no.3
• /
• pp.93-115
• /
• 2022

Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.

• Koreanishche Zeitschrift fur Deutsche Sprachwissenschaft
• /
• v.7
• /
• pp.105-125
• /
• 2003

Personal- und Reflexivpronomen stehen in einer komplementaren Beziehung zueinander. Die vorliegende Arbeit zeigt, welches von beiden Pronomen verschiedenen AcI-Konstruktionen jeweils richtig ist Vor allem stelle ich hier die These auf, dass Grammatik in erster Linie ein Regelwerk ist und dass dernzufolge $S\"{a}tze$ mit gleicher Struktur immer einheitlich und konsistent mit denselben Regeln $erkl\"{a}rt$ werden sollten: (1) a. Der Gefangen $l\"{a}sst$ den Polizisten auf ${\ast}sich_i/ihn_i$ achten. b. $Hans_i{\;}l\"{a}sst$ Maria zu $sich_i/{\ast}ihm_i$ kommen. (2) a. $Peter_i$ sieht Hans von ${\ast}sich_i/ihm_i$ betrogen. b. $Hans_i{\;}f\"{u}hlt$ die Freundin von $sich_i/{\ast}ihm_i$ weggezogen. Bei diesen Beispielen liegt der Verteilungsunterschied der Pronomina nicht an Grammatikregeln sondern am individuellen Sprachgebrauch. Ferner wird hier darauf hingewiesen, dass die AcI-Verben mit Ausnahme des Verbs lassen a1s 3-wertige Verben so wie die $S\"{a}tze$ in Beispiel (3) zu behandein sind D.h., die Struktur $f\"{u}r$ AcI-Konstruktionen sieht so aus wie (4b), nicht wie (4a). Betrachten wir dies noch einmal an einem Beispiel: (3) a. Ich sehe mich $m\"{u}de$ b. Ich $f\"{u}hle$ mich viel besser.

• Journal of Radiopharmaceuticals and Molecular Probes
• /
• v.8 no.1
• /
• pp.3-8
• /
• 2022

Alteration of the mGluR5 density is closely related to various brain diseases including schizophrenia, depression, Parkinson's disease, and Alzheimer's disease. Therefore, mGluR5 is considered as a valuable imaging biomarker for brain disease and many radiopharmaceuticals have been developed so far. Among them, [¹⁸F]FPEB has favorable pharmacokinetic characteristics, and this is the most frequently used radiopharmaceutical for preclinical and clinical studies. In the present study, we want to introduce the optimized radiosynthetic method for the routine production of [¹⁸F]FPEB using a GE TRACERlabTM FXFN pro module. In addition, the entire process was monitored with a webcam to solve the problems arising from the synthetic process. As a result, [¹⁸F]FPEB was prepared by nucleophilic substitution from its nitro- precursor at 120℃ for 20 min in dimethyl sulfoxide. Radiochemical yield was 13.7 ± 5.1% (decay-corrected, n = 91) with the molar activity of 84 ± 17 GBq/µmol at the end of synthesis. The radiochemical purity was determined to be above 96%. The manufactured [¹⁸F]FPEB injection for quality controls were carried out in accordance with an KIRAMS approved protocol, as per ICH and USP guidelines.

• Journal of Korean Physical Therapy Science
• /
• v.1 no.1
• /
• pp.135-144
• /
• 1994

The authors studied therapeutic effects and related clinical data retrospectively on a series of 48 consecutive patients with head injury who were referred to physical therapy and occupational therapy, Kosin University Medical Center during 1 year, from March, 1993. through March, 1994. The conclusions were as follows : 1. Average age of the subject patients was 50.6 years, their age remped from 14 to 72 years, and the incidence between male and femele was 1:1.1. 2. In respect to the educational level high school graduates showed the highest incidence 18 (39.1 %) of 46 cases, and in respect to economy level, middle class revealed the highest incidence, 31(64.6 %) in 48 cases. 3. The HBP was the most common cause of spontaneity injury, disclosing 19 cases in 35 patients(54.3%), whereas the main cause of traumatic injury was a traffic accident, 7 cases ( 53.8 %) in 13 patients. 4. As for the region of injury in the cases of spontaneity ICH was 14 persons (40%). In the cases of trauma, hematoma was seen in 6 cases(42.2 %) in 48 total cases ICH was seen in 17 cases (35.4 %) to be the most common region. 5. Among 35 persons, spontaneity CBR was the highest region of injury, 13 cases(37.1 %) ; the side of paralysis in extremities the right side showed higher incidence, 18 cas (1.4 %) as compared to the left, 16 cases(45.7%). In the case of traumatic injury, CBR was the highest region of injury, 4(30.8% )in 13 cases and as for the paralysis side, right side showed higher incidence 7 cases(53.8%) as compared to the left side 5 cases(38.5%). 6. In respect to recurrence, HBP was seen in 5 cases to be the most common cause, and as for the region of injury, CBR was the highest. 7. A period of rehabilitation therapy in the cases of physical therapy the highest term was 1-2 month, 14 persons(29.2%). As for occupational therapy within 2 week-term was the highest, 24 persons(50%). 8. Physical strenth grade M.T in the cases of the upper extrimities before therapy, the low mark(grade 0) was 30 cases(62.5%), compared to the high mark(above grade 3)seen in 1 case(2.1%), And after therapy, the lowest mark(grade 0)was seen in 5 cases(10.4%) where as the high mark(above grade 3)was seen in 29 cases(60.4%). In the case of the lower extremities before therapy, the mark(below grade 1)was 37 cases(77.1 %), while the high mark(above grade 3)was seen n 4 cases(8.4%). And after therapy the low mark(below grade 1)was seen in 5 cases (10.4 %) and the high mark (above grade 3)was seen in 29 cases(60.4 %). 9. Before therapy conigtive function-level evaluation utilized R.L.A.L, the low mark(below level 3)was seen in 9 cases(18.8%), while the high mark(above level 7)was seen in 18 cases(37.5%). And after therapy the low mark (below level 3)was 4 cases(8.3%) and high mark(above level 7)was seen in 38 cases(79%). 10. After rehabilitation therapy, patients who were able to walk independently were 29 persons(60.4%), among which 16 cases(55.2%) depended on cane. The ratio between the cases who were able to walk and unable to walk was 1.5:1.

• Journal of the Society of Cosmetic Scientists of Korea
• /
• v.33 no.4
• /
• pp.263-267
• /
• 2007

Parabens are used in nearly all types of cosmetics and toiletries because they are formulated well and have broad spectrum of activity, interness, low costs and excellent chemical stability in relation to pH. 2-phenoxyethanol and chlorphenesin are common preservatives which are usually used in combination with parabens in cosmetics. Toxicity of parabens is generally low but application of parabens to damaged or broken skin has resulted in sensitization. Moreover, the possibility of their estrogenic potential, anesthetic effects and reproductive toxicity has been reported. Consequently there are some regulations in use of parabens. And the maximum permitted concentrations of chlorphenesin and 2-phenoxyethanol in cosmetic products are authorized by the same reasons. So it is important to control and estimate the amount of parabens in products. In this article, we proposed a valid method for the simultaneous determination of 8 preservatives including parabens in a short time using ultra performance liquid $chromatography^{TM}\;(UPLC^{TM})$. Separation of eight components was achieved in less than 10 min and resolutions were reasonable (USP resolution ${\geqq}\;2$). And limit of detection and quantification were evaluated. The method was suitably validated for specificity, linearity, precision (repeatability, intermediate precision) and accuracy for assay (recovery) based on International conference on harmonisation (ICH) guideline. The method was applicable to analysis of preservatives in cosmetic products.