• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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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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• 제1권3호
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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.

• 월간포장계
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• 통권300호
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• pp.58-60
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• 2018

• 식품과학과 산업
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• 제49권3호
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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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• 제35권1호
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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.

• 한국수의병리학회지
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• 제1권2호
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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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• 제35권6호
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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.

• 농약과학회지
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• 제9권1호
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• pp.41-50
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• 2005

본 연구에서는 인삼성분의 조성을 변화시키지 않으면서 잔류농약만 제거시키는 방법을 pilot plant system에서 확립하고자 하였으며, 원래의 제조 공정에 따라 제조한 제품과 농약제거 공정을 적용하여 제조한 제품에서 155종의 잔류농약성분을 모니터링하였으며, 인삼성분을 비교 검토하였다. 농약제거공정을 거친 4가지의 공정은 control test에 비하여 잔류농약의 양이 많이 감소하였다. 즉, hexane을 이용한 공정에서 잔류농약이 제거되었고, 농약의 제거율을 높일 수 있는 가장 효율적인 방법은 헥산침지후 건조과정을 거친 공정으로 나타났다. 개발된 방법은 인삼농축액의 성분에는 영향을 미치지 않고 잔류농약만 89.1% 제거할 수 있었다.

• 한국독성학회:학술대회논문집
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• 한국독성학회 2006년도 추계학술대회
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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.

• 한국식품과학회지
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• 제35권4호
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• pp.748-751
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• 2003

2002년 4월 스웨덴의 국립식품청인 SNFA(Swedish National Food Administration)에서 발암의심 물질인 아크릴아마이드가 식품에서 검출되었다고 보고하였다. 그 후 영국, 노르웨이, 스위스, 독일, 미국, 일본, 캐나다 등에서 가열 처리된 식품 중 아크릴아마이드 생성을 확인하였다. 이에 본 연구에서는 미국 FDA에서 추천하는 Liquid chromatography-tandem mass spectrometry(LC-MS/MS) 방법을 이용하여 국내 식품의 아크릴아마이드 검출양을 모니터링하였다. 모니터링 결과, 원료식품인 생감자와, 쌀을 원료로 하여 가열한 밥에서는 아크릴아마이드가 검출되지 않았으며, 도넛은 <30, 36 ppb 검출되었다. 건빵은 854, 1081 ppb 식빵에서는 <30 ppb, 시리얼은 $51{\sim}283\;ppb$ 검출되었다. 감자칩과 감자스낵은 $598{\sim}1709\;ppb$, 비스킷은 $115{\sim}241\;ppb$, 후렌치 후라이는 $341{\sim}1896\;ppb$ 검출되었다. 커피는 $160{\sim}220\;ppb$, 초코릿은 $47{\sim}63\;ppb$ 검출되었다.