• Journal of Pharmaceutical Investigation
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• 제34권4호
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• 한국어병학회지
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• 제27권1호
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• pp.67-75
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• 2014

Aquaculture drugs have used to prevent disease in aquaculture field for many years. In spite of many advantages, overdose and abuse may cause environmental pollutions and antibiotic resistances. Many countries try to protect the environment, biospecies and food safety. Recently, Korea enact laws and ordinances such as the Aquatic Animal Disease Control Act. The purpose of this act to contribute to the stable production and control system for aquatic diseases. The Maximum residue limits (MRLs) of aquaculture drugs have been established by Ministry of Food and Drug Safety (MFDS) and Drug licensing was in National Fisheries Research and Development Institute (NFRDI) by Aquatic Animal Disease Control Act. There is 750 items in aquaculture drugs and these are classified into 4 group, which is approval, necessary for prescription, unregulated and safety drug, and banned drug. MRLs of 30 items in aquaculture drug have been established by Food Sanitation Act. Future research is required to determine the suitable for abundant varied fishes of drugs for side effects and safety.

• 대한의생명과학회지
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• 제27권3호
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• pp.121-133
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• 2021

Antibody-drug conjugates (ADCs) are drawing much interest due to its great potential to be one of the important options in cancer treatments. ADCs are acting like a magic bullet which delivers cytotoxic drugs specifically to cancerous cells throughout the body, thus attacks these cells, while not harming healthy cells. ADCs are complex molecules that are composed of an antibody having targeting capability and linked-payload or cytotoxic drug killing cancerous cells. The key factors of the success in the development of ADC are selection of appropriate antibody, cytotoxic payload and linker for conjugation. Recently there was considerable progress in ADCs development, and a large number of ADCs gained US FDA approval. About 80 new ADCs are under active clinical studies. In this review we present a brief introduction of the US-FDA approved ADCs and global situation in the clinical studies of ADC pipelines. We address an overview on each component of an ADC design such as target antigens, payloads, linkers, conjugation methods, drug antibody ratio. In addition, we discuss on the trend of ADC market where global big pharmas and domestic biopharmaceutical companies are competing to develop safer and more effective ADCs.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

• Toxicological Research
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• 제22권2호
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• pp.109-116
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• 2006

Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline 'S7A: Safety Pharmacology Studies for Human Pharmaceuticals' has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer 'The Guideline for General Pharmacology' into 'The Guideline for Safety Pharmacology'. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines 'S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals' and 'E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs' to apply our drug approval systems.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제49권2호
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• pp.68-74
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• 2023

Objectives: Drug holidays are suggested to reduce the formation of osteonecrosis in patients under intravenous (IV) bisphosphonates (BPs) therapy. The objectives of this study are to evaluate the incidence of medication-related osteonecrosis of the jaw (MRONJ) following tooth extraction in cancer patients using IV BP, and to assess the effect of drug holiday on the development of MRONJ. Patients and Methods: A manuel search of the patient folders of Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University was undertaken to identify cancer patients who used IV BPs and had at least one tooth extraction between 2012 and 2022. Patents' age, sex, systemic condition, the type of BP used, duration of BP used, number of tooth extraction, duration of drug holiday, localization of tooth extraction and incidence of MRONJ were recorded. Results: One hundred nine teeth were removed from 57 jaws in 51 patients. All tooth extractions were performed under perioperative antibiotic prophylaxis and with primary wound closure. The incidence of MRONJ was 5.3%. Stage 1 MRONJ developed in 3 patients (only one had a drug holiday). The median duration of drug holiday was 2 months. No significant difference between the patients with and without a drug holiday and MRONJ development was found (P=0.315). The mean age of patients developed MRONJ was 40.33±8.08 years. A statistically significant difference was found between age and MRONJ development (P=0.002). Conclusion: The effect of a short-term drug holiday on the development of MRONJ may be limited because BPs remain in bone tissue for a long time. Drug holidays should be applied with the approval of an oncologist with other preventive measurements.

• Journal of Digestive Cancer Research
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• 제11권2호
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• pp.104-107
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• 2023

The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

• Biomolecules & Therapeutics
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• 제8권3호
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• pp.269-275
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• 2000

Silibinin(silybin) is the active component of silymarin from Silybum marianum and has hepato-protective effect. It is water-insoluble and has low bioavailability. To improve its bioavailability, self-micro-emulsifying drug delivery system (SMEDDS) has been developed by Hanmi Pharmaceutical Company (Silyma $n^{R}$ 140 soft capsule). In this study, the pharmacokinetic profiles of Silyma $n^{R}$ were examined and compared it with a reference preparation, L Caps140 of B Pharmaceutical Company. This study was approved by Yonsei University Severance Hospital IRB(approval No. CR0004) and followed the bioequivalence test guideline of Korean FDA. Eighteen healthy adult volunteers were allocated based on 2$\times$2 Latin square cross-over design. They were given 2 capsules (each contains silymarin 140 mg (60 mg as silibinin)) of either drug at each period and crossed over after a week of drug-free washout period. Blood concentration of silibinin was measured by HPLC. The $C_{max}$ and AUC of the Silyma $n^{R}$ were 1542.0 $\pm$ 402.7 ng/ml and 3323.3 $\pm$ 824.7 ng.h/ml, respectively, and were significantly higher than those of reference preparation. The Tmax was 0.8 $\pm$ 0.3 h and significantly shorter than reference preparation. The $K_{e}$ and $T_{1}$2/ of both drugs were comparable. Percent differences in means against reference preparation were +88.3% for AUC, +222.6% for $C_{max}$, and -61.1% for $T_{max}$./.>././.>./.

• Toxicological Research
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• 제1권1호
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• pp.31-41
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• 1985

The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

• 한국데이터정보과학회:학술대회논문집
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• 한국데이터정보과학회 2006년도 추계 학술발표회 논문집
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• pp.43-48
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• 2006

In 2001 US FDA proposed a draft guidance for future in vivo bioequivalence studies. The guidance suggested specific criteria for new drug sponsors to show prescribability and switchability in bioequivalence testing for approval of generic drugs. However, there is less acceptance of the need to change statistical procedures and study designs from those currently used to assess the current criterion of average bioequivalence. The measures of population and individual bioequivalence testing are introduced and statistical procedures for them are discussed.