• 품질경영학회지
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• 제38권1호
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• pp.96-100
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• 2010

The shelf-life of pharmaceutical products is the time that the average product characteristic remains within an approved specification after manufacture. Since the true shelf-life of a drug product is typically unknown, it has to be estimated based on assay results of the drug characteristic from a stability study usually conducted during the process of drug development. The nonparametric statistical methods of assessing the shelf-life of drug are considered with the current FDA regulations. Some simulation studies of nonparametric methods are also presented with the discussion.

• Food Quality and Culture
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• 제3권2호
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• pp.74-81
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• 2009

This study investigated consumers' recognition on shelf life of health functional foods to set up their rational expiration date. For this study 107 male and female adults aged 20 to 59 years were randomly selected as major consumers of health functional foods. And their data were analyzed with SPSS 17.0. The questionnaire included questions asking a consumer's recognition on the shelf life of health functional foods and how to treat health function food passing its shelf life. In this study, the consumers were found to pay attentions considerably to the shelf life. But most of them did not know an accurate meaning of the shelf life of health functional food and mistook it for expiry date. In addition, the consumers doubted safety of health functional foods passing the shelf life. Therefore, education for consumers about an accurate meaning of the shelf life was needed. The results of this study were considered to be helpful to set up a reasonable expiration date for health functional food.

• 품질경영학회지
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• 제36권1호
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• pp.1-6
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• 2008

The purpose of stability study of pharmaceutical products is to establish the shelf life based on the change of the quality with time. Stability study generally consists of a random sample of dosage units from a batch or several batches placed in a storage room and periodically assayed for their drug content. The statistical methods of assessing the shelf-life of drug in the market is considered with the current KFDA regulations. An illustrated application to some stability data from the pharmaceutical industry is also presented with the discussion.

• Applied Biological Chemistry
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• 제51권4호
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• pp.329-333
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• 2008

This study was designed to estimate the shelf-life of the popular chilled foods kimbab (rice rolled in dried laver), samgak kimbab (triangular rice rolled in dried laver), eomook (fish surimi, boiled fish paste) mook (acorn-starch jelly), and tofu (soybean curd) in large discount markets and convenience stores. Different types of chilled foods were stored at 5, 7, and 10 for 7 and 28 days, and changes in the total numbers of the aerobic bacteria were monitored. Values of 6 and 7 log cfu/g were used as the standard. Ready-to-eat foods stored at 5 showed a much longer shelf-life compared to storage at 10. The respective percentage increases in the shelf-life observed at both 7 and 5 were kimbab (70%, 171%), samgak kimbab (87%, 143%), soybean curd (46%, 95%), fish surimi (46%, 99%), and mook (45%, 87%). To reduce the microbiological contamination, storages at 7 and 5 are recommended for the increases of 45-88 and 87-171% in the shelf-life of these chilled foods.

• 한국식품위생안전성학회지
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• 제34권1호
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• pp.94-99
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• 2019

비살균액란은 열처리 공정을 거치지 않고 가공 및 유통됨으로 인하여 보관 온도와 시간에 의하여 품질에 있어서 문제될 수 있다. 이에 본 연구에서는 국내에서 제조한 비살균액란의 유통기한 산출 및 평가를 위하여 전국에 8개 액란 공장에 대한 일반세균수가 가장 높은 가공장에서 동절기와 하절기에 비살균 전란액, 난황액, 난백액을 각각 채취하여 $5^{\circ}C$, $10^{\circ}C$, $15^{\circ}C$, $25^{\circ}C$에 보관하면서 관능검사(시각, 후각), 이화학적 검사(pH, 휘발성 염기질소), 미생물 검사(일반세균수, 대장균 군수)를 각각 실시하였다. 유통기한 설정은 비살균 액란의 품질지표 중국내에서 현재 법적규격으로 적용되고 있는 일반세균수(500,000 이하/g)와 대장균군수(100 이하/g) 기준으로 산출하였다. 반면 법적 규격이 없는 항목인 VBN, pH는 각 품질지표와 관능검사(9점 척도법)의 상관관계를 나타내는 선형 회귀방정식을 구하여 이 식에 관능검사의 한계 규격 값 5점(9점 척도법 기준)을 대입하여 해당 품질지표의 규격 값으로 산출하여 유통기한으로 설정하였다. 그 결과 유통기한은 생물학적 특성인 대장균 군수에 가장 큰 영향을 받고, 균의 증식이 제한되는 $5^{\circ}C$와 $10^{\circ}C$에 보관된 전란액과 난백액의 유통기한은 이화학적 특성인 VBN에 영향을 받는 것으로 나타났다. 유통기한은 전란액은 $5^{\circ}C$에서 5일, $10^{\circ}C$에서 5일, $15^{\circ}C$에서 <1일, $25^{\circ}C$에서 <1일로 각각 산출되었다. 난황액은 $5^{\circ}C$, $10^{\circ}C$, $15^{\circ}C$, $25^{\circ}C$에서 5일, 1일, <1일, <1일로 난백액은 7일, 5일, <1일, <1일로 각각 산출되었다.

• 한국식품영양학회지
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• 제26권4호
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• pp.655-662
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• 2013

This study was carried out to investigate the changes in the quality properties of red pepper Yukwa (red pepper liquid fermented with lactic acid bacteria was added to the Yukwa) during the storage period. To determine the shelf life of red pepper Yukwa, the rice Yukwa (control) and red pepper Yukwa were stored at 15, 25, and $35^{\circ}C$ for 70 days. Also, the quality properties of red pepper Yukwa, such as acid value, peroxide value, texture, color, and sensory evaluation were measured. Although the acid value of rice Yukwa and red pepper Yukwa increased during storage, the red pepper Yukwa showed a lower acid value score (1.09mg KOH/g) than that (1.19mg KOH/g) of the rice Yukwa. Nevertheless, these values did not exceed the guideline maximum values of 2.0 g KOH/g specified in the Korean Food Code. The peroxide values of samples had significantly increased after 42 days. Especially, the peroxide value scores for the rice Yukwa and red pepper Yukwa were the highest at 146.49 and 126.79 meq/kg at $35^{\circ}C$, respectively. Hardness and brittleness in textural properties increased up to 70 days. The sensory values for the red pepper Yukwa for overall acceptance, taste;texture and appearance were the highest. The results indicated that by using the 'Visual Shelf life Simulator for foods' of the Korea Food and Drug Administration (KFDA) the shelf life of red pepper Yukwa is estimated to be 274.78 days.

• 한국신뢰성학회지:신뢰성응용연구
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• 제17권1호
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• pp.1-10
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• 2017

Purpose: This study aims at omitting the initial testing of the ASRP by determining the initial test year. Methods: This study is to determine of the initial test year for one-shot system using validity assessment of drugs. Results: Procedures for determining the initial test duration of the one shot system and examples of omitting the tests are presented. Conclusion: Using this method, the time and labor required for testing can be saved by omitting the initial testing of ASRP.

• 한국식품과학회지
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• 제43권1호
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• pp.17-22
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• 2011

수산물 중 포름알데히드 함량 수준을 평가하기 위하여 어류, 패류, 갑각류 및 연체류 14종을 비교 분석하였다. 수산물 중 포름알데히드 함량은 0.07 mg/kg에서 최고 73.74 mg/kg 수준으로 측정되었다. 어류에서의 함량은 평균 1.29 mg/kg, 패류에서의 함량은 평균 1.70 mg/kg, 갑각류의 경우 평균 7.90 mg/kg으로 어류와 패류에 비교해 유의적으로 높았으며, 특히 꽃게의 경우 최대 73.74 mg/kg까지 함유되어 있었다. 연체류에서의 함량은 평균 3.06 mg/kg수준으로 평가되었다. 유통형태에 따른 함량에서는 대체적으로 살아있는 상태로 유통되는 활어나 활패의 경우 냉장, 냉동 유통보다 낮은 함량을 보였다. 이는 포름알데히드가 사후에 여러 가지 복잡한 과정을 거쳐서 생성되는 것과 함께 수산물에 특이적인 물질인 TMAO가 사후 효소분해 등의 여러 기작을 통해 DMA와 포름알데히드로 분해되어 증가하기 때문인 것(18-21)으로 사료된다. '국민영양조사'와 '영양 및 위해평가 시스템 구축' 연구보고서를 참고하여 노출량 평가를 한 결과, 대상 수산물에 대한 한국인의 평균 일일 섭취량으로 섭취되는 포름알데히드는 0.070 mg/day로 ADI의 0.58% 수준밖에 되지 않았으며, 극단적인 섭취량 평가를 위한 99th 수준에서 섭취되는 포름알데히드는 1.574 mg/day로 ADI의 13.12%에 불과하여 안전한 수준이지만, 더 정확한 노출량 평가를 위해서는 다른 수산물을 포함한 식품에 대한 포름알데히드 함량의 조사와 더불어 섭취량 조사 또한 뒷받침되어야 할 것으로 판단된다.

• Journal of Pharmaceutical Investigation
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• 제40권spc호
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• pp.9-17
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• 2010

Polymorphism has been recognized to be a critical issue throughout the drug product development process. Most of solid phase drugs have polymorphism, which has generated a great deal of interest and the field has been evolving rapidly. Preferably, thermodynamically most stable form of a drug substance is selected to obtain consistent bioavailability over its shelf life and various storage conditions. Moreover, it has the lowest potential for conversion from one polymorphic form to another. However, metastable or amorphous forms may be used intentionally to induce faster dissolution rate for rapid drug absorption and higher efficacy. For pharmaceutical industry, polymorphism is one of the key activities in form selection process together with salt selection. This article introduces the main features in the investigation of solid form selection especially polymorphic behavior with thermodynamic backgrounds, physicochemical properties with solubility, dissolution, and mechanical properties, and characterization techniques for proper analysis. The final form can be recommended based on the physicochemical and biopharmaceutical properties and by the processability, scalability and safety considerations. Pharmaceutical scientists especially in charge of formulation need to be well aware of the above issues to assure product quality.

• Journal of mucopolysaccharidosis and rare diseases
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• 제1권1호
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• pp.28-30
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• 2015

Biologics present a challenge to both the manufacturer and end user. They must usually be formulated as parenterals. However, they are often unstable in liquid form, due to their complex structure and composition. In that case, they must be manufactured using highly specialized processes, such as lyophilization (freeze-drying). Lyophilization nearly eliminates stability issues. Reducing a compound's sensitivity to temperature prolongs its shelf life. However, reconstitution can be cumbersome, involving multiple steps that increase the potential for error. Dual-chamber technology provides an effective alternative, combining a lyophilized drug and diluent in a closed system and enabling reconstitution in a few simple steps.