As the pharmaceutical industry in Korea is reaching the golden era of drug discovery due to increased investments in research and development and government funds, the need for a more efficient tool for the quantitative analysis has emerged. Therefore, the demand for pharmacometrics (PMx) consultancy services increased. Higher quality service suitable for regulatory submission and out-licensing deals were desired. In this analysis, we compiled and summarized 3 years of experiences of Q-fitter, the first PMx consultancy service company providing PMx analysis to the pharmaceutical industry in Korea. The projects were organized by companies, company types, indications, therapeutic areas, drug development stages, purposes, and scope of services. Within each category, we subcategorized the sections and assessed proportions and a year-over-year trend. As a result, we observed an increase in the number of projects in an average of ~170% per year, with the most frequent types of companies collaborated being the domestic pharmaceutical companies. Among the projects, ~72% involved modeling and simulation using population pharmacokinetic (PK) models, and the other included non-compartmental analysis (NCA), drug-drug interaction (DDI) prediction, and interpretation of the modeling results. The most sought-after purpose in PMx analysis was first-in-human (FIH) dose prediction followed by PK analysis, next clinical trial prediction, and scenario-based simulation. Oncology has been the top therapeutic area of interest every year consisting of ~38% of total projects, followed by Neurology (~13%). From this review, we were able to characterize the PMx service needs and spot the trend of current PMx practices in Korea.
Drug Discovery ; Drug Industry ; Financial Management ; Investments ; Korea ; Neurology

Objectives: The purpose of this study was to classify the users of a university counseling center and define their characteristics using the information from the service application written by them as one of the approaches to improve the efficiency of the center. Methods: The participants were a total of 300 users of the university counseling and affiliated psychiatry center in the local science and technology institute. The service application form used in this study contained questions on personal information, overall satisfaction with university life and interpersonal relationships, problem areas and symptoms, depression, anxiety, sleep, family history, suicidal thoughts, experiences of suicide/self-harm attempts, and a functional impairment questionnaire. First, a latent class analysis was performed to classify the layers and define them. Also, a tree-based model was used to confirm the characteristics of the service applications of the suicide/self-harm attempt experience group. Results: A total of 5 layers were found to be the most suitable fit. They were named the ‘health concern type,’ ‘relation problem type,’ ‘depression-sleep problem combined type,’ ‘complex problem type,’ and ‘sleep problem type.’ The variable that best discriminates the suicide/selfharm attempt experience group was question 5 of the Patient Health Questionnaire (PHQ-9). The frequency of selection in the impulsivity domain among the problem types and question 9 of the PHQ-9 was followed. Conclusion The results of this study indicate that five types of discriminatory interventions are possible based on the characteristics of the service application. The application can thus be used as basic data for increasing service efficiency in university counseling.

The prevalence of Atopic Dermatitis (AD), a non-infective chronic inflammatory skin disease, is increasing worldwide. Avoiding the allergen is the basic principle in the treatment of AD. However, when the allergen is food, excessive restriction can lead to nutrition deficiency. The objective of the study was to examine the status of the dietary restriction and compare the caregiver's restriction practice with doctor's recommendation in Korean children with AD. A total of 158 children diagnosed with Atopic Dermatitis were recruited for this study. Information about foods that aggravate AD symptoms and food restriction were collected from the mothers of 158 children aged 6 month-5 year with AD using questionnaires. Food restriction recommendation by doctor was collected through medical chart. McNemar and Margianl homogeneity tests were used to detect a relationship between food restriction recommended by doctor and current practice by mother. There were significant proportion differences of food restriction for each food between by doctor and mother. We found 75.9% of children were avoiding eggs although only 61.4% were recommended for egg restriction by a doctor. Children with restriction of more than 4 kinds of food were 53.2% compared to 13.3% by doctor. Excessive restrictors tended to be younger and diagnosed at younger age. The caregivers of excessive restrictors had trends of "being older" and "having higher income". Avoidance of common foods in children without food allergy could result in malnutrition or impaired growth. Nutrition education is needed for sound practice and nutrition care in children with Atopic Dermatitis as well as interactive communication between caregivers and experts.
Aged ; Caregivers ; Child ; Dermatitis, Atopic ; Eggs ; Food Hypersensitivity ; Humans ; Malnutrition ; Mothers ; Ovum ; Prevalence ; Surveys and Questionnaires ; Skin Diseases

BACKGROUND: Levodropropizine is non-opioid agent whose peripheral antitussive action may result from its modulation of sensory neuropeptide levels. Currently, levodropropizine 60 mg is taken three-times daily. A controlled release formulation of levodropropizine (levodropropizine CR) 90 mg was developed, which can be taken twice daily. The aim of this study was to evaluate the safety and pharmacokinetic characteristics after multiple oral administrations of levodropropizine CR 90 mg tablets in healthy male volunteers. METHODS: A randomized, open-label, cross-over study was conducted in 24 healthy male volunteers. Each subject received levodropropizine syrup 60 mg three times daily or levodropropizine CR 90 mg twice daily for 3 days. Blood samples for pharmacokinetic analysis were collected pre-dose and up to 24 hours on day 4. Pharmacokinetic analysis was conducted by non-compartmental method. Safety assessments including monitoring adverse events, laboratory tests, vital signs, physical examinations and ECGs were performed throughout the study. RESULTS: A total of 20 male volunteers completed the study. The maximum steady-state plasma concentration (Css,max) of levodropropizine syrup and levodropropizine CR were 313.28 ng/mL and 285.31 ng/mL and time to reach Css,max (Tmax,ss) were 0.48 hr and 0.88 hr, respectively. The area under the concentration-time curve to the last measured concentration of two groups were 2345.36 hr x ng/mL and 2553.81 hr x ng/mL, respectively. There was no serious adverse event. CONCLUSION: Levodropropizine CR 90 mg tablet was safe and well-tolerated when administered twice daily for 3 days. No statistically significant differences were seen in Css,max and AUCss,24hr between the two formulations. This study provided pharmacokinetic evidences that the twice-daily dosing regimen of levodropropizine 90 mg may substitute the conventional 3-times-daily regimen of levodropropizine 60 mg.
Administration, Oral ; Cross-Over Studies ; Electrocardiography ; Humans ; Male* ; Methods ; Neuropeptides ; Pharmacokinetics* ; Physical Examination ; Plasma ; Tablets ; Vital Signs