• Journal of Korean Society for Quality Management
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• v.38 no.1
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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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• v.3 no.2
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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.

• Journal of Korean Society for Quality Management
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• v.36 no.1
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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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• v.51 no.4
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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.

• Journal of Food Hygiene and Safety
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• v.34 no.1
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• pp.94-99
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• 2019

The objective of this study is to establish the shelf life of non-pasteurized whole egg, egg yolk and egg white liquid. Each sample was stored for two weeks at $5^{\circ}C$, $10^{\circ}C$, $15^{\circ}C$, and $25^{\circ}C$, and then sensory, microbial, and physicochemical tests were performed periodically. The estimation of shelf life was based on the microbial standards of total viable counts and coliforms. The chemical properties highly correlated with the sensory evaluation were also used. Our results showed that the shelf life was the most influenced by microbial properties. Exceptionally, however, whole egg and white liquid stored at $5^{\circ}C$ and $10^{\circ}C$ with limited bacterial growth were affected by chemical property. The shelf life of the three non-pasteurized liquids was calculated to be less than one day at over $15^{\circ}C$. At $5^{\circ}C$ and $10^{\circ}C$, the shelf life was calculated to be 5 d and 1 d for egg yolk liquid, 5 d and 5 d for egg white, and 7 d and 5 d for whole egg, respectively. Therefore, it is advisable to establish reasonable shelf life in the more specific manner based on consideration of these findings.

• The Korean Journal of Food And Nutrition
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• v.26 no.4
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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.

• Journal of Applied Reliability
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• v.17 no.1
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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.

• Korean Journal of Food Science and Technology
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• v.43 no.1
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• pp.17-22
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• 2011

In this study, formaldehyde in various fisheries products was previously derivatized with acetylacetone and subsequently analyzed by using HPLC-PDA. The formaldehyde contents ranged from 0.07 to 73.74 mg/kg. The compound was significantly higher in both mollusks (0.34-12.38 mg/kg) and crustaceans (0.09-73.74 mg/kg) than in fish (0.07-3.35 mg/kg) and shellfish (0.50-3.90 mg/kg). This difference was due to storage time and temperature. In general, fish and shellfish are sold live or in refrigerated form with shorter a shelf-life, but mollusks and crustaceans are distributed in cold or frozen systems with a longer shelf-life. Using food intake data from a report of the National Health and Nutrition Survey, the daily human exposure level to formaldehyde was 0.58% of the ADI. The results from this study might provide fundamental information to confirm naturally-originating or fraudulent formaldehyde treatment in fisheries products.

• Journal of Pharmaceutical Investigation
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• v.40 no.spc
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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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• v.1 no.1
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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.