• Proceedings of the PSK Conference
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• 2003.04a
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• pp.91-92
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• 2003

Virtually every state in US has adopted laws and regulations that mandate the generic substitution of brand-named prescription drugs in order to reduce sky-rocketing drug costs. In the late 1970s, many state governments began to recognize the need of generic substitution and requested Food and Drug Administration (FDA) to consult with this issue. FDA did consult which drugs were interchangeable each other based upon the available scientific and experimental evidences given to the agency along with New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). (omitted)

• Interdisciplinary Bio Central
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• v.1 no.3
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• pp.10.1-10.5
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• 2009

Toxicity is usually investigated using a set of standardized animal-based studies which, unfortunately, fail to detect all compounds that induce human adverse events and do not provide detailed mechanistic information of observed toxicity. As an alternative to conventional toxicology, toxicogenomics takes advantage of currently advanced technologies in genomics, proteomics, metabolomics, and bioinformatics to gain a molecular level understanding of toxicity and to enhance the predictive power of toxicity testing in drug development and risk/safety assessment. In addition, there has been a renewed interest, particularly in various government agencies, to prioritize and/or supplement animal testing with a battery of mechanistically informative in vitro assays. This article provides a brief summary of the issues, challenges and lessons learned in these fields and discuss the ways forward to further advance toxicology using these technologies.

• The monthly packaging world
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• s.300
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• pp.58-60
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• 2018

• Food Science and Industry
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• v.49 no.3
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• pp.55-61
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• 2016

Even though the food safety system in the United States is one of the best in the world, many millions of people become sick and thousands die from foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. Large recalls of United States Department of Agriculture (USDA) and the Food Drug and Administration (US FDA)-regulated food products due to findings of E. coli O157:H7, Listeria, Salmonella, and other problems occur each year. As the US FDA Food Safety Modernization Act (FSMA) passed in 2011, FSMA will require food processing, manufacturing, shipping, and other regulated entities to conduct an analysis of the most likely safety hazards and to design and implement risk-based controls to reduce or eliminate these hazards. FSMA also mandates increased scrutiny of food imports, which account for a growing share of U.S. food consumption; food import shipments will have to be accompanied by documentation showing that they can meet safety standards that are at least equivalent to those in the U.S. On September 17, 2015, the US FDA published final rules for Preventive Controls for Human and Animal Food and, continuing into 2016, the US FDA intends to finalize the remaining five rules it has proposed to implement FSMA. Among these rules, this article will review and discuss Preventive Controls for Human Food Rule and its components, and suggest how to comply with these FSMA rules as foreign human food and ingredients suppliers to the US.

• Journal of Pharmaceutical Investigation
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• v.35 no.1
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• pp.57-63
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• 2005

Numerous drugs are chiral because they possess one or more chiral centers. Enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. However, the significance of stereochemistry of drugs in their therapeutic uses has received relatively little attention until recently. The US FDA issued a guideline on stereoisomeric drugs in 1992, and the European agency describes tests for new drug substances which are optically active in an ICH(International Conference of Harmonization) guideline. According to the guidance, enantiomers may differ in their pharmacokinetic, pharmacological and toxicological properties. Therefore, in this paper, we examined the recently published Canadian guidance, stereochemical issues in chiral drug development, which will be references to make a guidance on stereochemical issues in chiral drug development in Korea.

• Korean Journal of Veterinary Pathology
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• v.1 no.2
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• pp.91-96
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• 1997

General steps in the discovery and development of novel drugs in the United States are presented. The first step is the discovery of novel drugs. Brief histories and mechanisms of a few novel drugs in the American market are outlined. In this presentation preclinical animal toxicologic studies (drug safety evaluateion) are emphasized in regard to drug development. When preclinical animal studies have defined the toxicity and the doses at which it occurs an Investigational new Drug Application (IND) is submitted to the Food and Drug Administration (FDA) An IND notifies the FDA the intention to begin testing a novel drug in human subjects.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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• pp.471-481
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• 2005

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

• The Korean Journal of Pesticide Science
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• v.9 no.1
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• pp.41-50
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• 2005

For the removal of residual pesticides in ginseng extracts, we estabilished the removal process using pilot plant system, the characteristic components of ginseng maintains only. According to the agricultural chemical removal process, we monitored residual pesticides of 155 species, compraing the characteristic components of ginseng. The process of 4 types of agricultural chemical removal process compared to the control test was appeared that the residual pesticides were eliminated. As results above, the most efficient method of the possibility of raising the removal ratio of the agricultural chemical construction process was dried process of hexane after dipping and also remaining quality of the hexane appeared lowly. Besides, the removal process had an effected on the ginsenocide os ginseng, only the residual pesticides will be able to remove.

• Proceedings of the Korean Society of Toxicology Conference
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• 2006.11a
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• pp.75-79
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• 2006

The United States Food and Drug Administration is responsible for ensuring US residents receive safe and effective medicines. Since blood levels of drugs are correlated with pharmacological effect, FDA closely regulates how those blood levels are measured. The FDA has established requirements for bioanalytical analyses such as minimum method validation, SOP, and reporting criteria. The FDA also has standards for computer validation which must be followed to ensure the data are reliable. Data presented to the Agency are scrutinized to ensure they are accurate and a true reflection of the raw data generated in a study. To verify the quality of data, FDA has developed an inspection program. The specific requirements of the FDA related to bioanalysis will be discussed.

• Korean Journal of Food Science and Technology
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• v.35 no.4
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• pp.748-751
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• 2003

Acrylamide is considered as potential carcinogen and genotoxicant. Swedish National Food Administration reported that acrylamide was detected in heat treated starch rich food products. Acrylamide formation during food processing was confirmed by researchers of other countries including UK, Norway, Japan, Switzerland, and United States. It is noticed that the formation of acrylamide in potato products was greater than other food products. It may be due to high concentration of asparagine and glucose in potato products comparing to those of other food products. Interaction between asparagine and glucose during heat treatment resulted in acrylamide formation via Maillard reaction. Analytical method (LC-MS/MS) adopted by FDA was performed to monitor acrylamide concentrations in domestic food products. Acrylamide quantitation in several food categories, such as raw materials, boiled foods, fried foods, hardtacks, breads, breakfast cereals, potato chips, french fries, biscuits, and others, were carried out.