• Proceedings of the International Microelectronics And Packaging Society Conference
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• 2000.04a
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• pp.27-27
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• 2000

• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• The Korean Journal of Applied Statistics
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• v.24 no.3
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• pp.495-503
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• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• Proceedings of the Korean Society for Quality Management Conference
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• 2009.10a
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• pp.227-229
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• 2009

Recent discussions in the active growth strategy based on getting a green environment, changes in the management of companies involved in environmental management is the analysis of various risk factors and the green growth at the same time the company's growth strategy is required. Thus, the corporate position on the green growth strategy based on risk management to analyze and respond to face reality, and respond to the scene of the applied methodology is required. In this study, contact the section of Environment to assess potential business risks that the EMEA Environment Mode Effects Analysis methodology through research and development company's in, contact the section of Environment to effectively analyze risk management by addressing the degree of risk assessment as a future-oriented and objective can manage is to provide technical management model.

• Proceedings of the Korean Reliability Society Conference
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• 2005.06a
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• pp.393-404
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• 2005

The environmental problem is a main subject of the 21C and an environment destruction phenomenon by various kinds of environmental materials is reaching serious level. Nations to be classified as the environmental developed country, are born again environmental rich country. And they earn a large income by trade Every kind environmental resource in an international commercial transaction. Especially, the study that a reliability assessment method to prevent to reliability problem to be happened when the solder lead(lead-free solder), non-cd component, non-bromide component(without the polybrominated biphenyls(PBB) and polybrominated diphenyl ethers(PBDE))and hexavalent chromium(Cr VI) clearance component and mercury-free applied to electronic equipment is progressed. As the result of the study for applying of a reliability assessment technique of lead-free solder that recognized the most of urgent problem at the company, combination accelerated life test could taken by adding and appling the part of a humidity acceleration part to Eyring Model which is proposed by R.E.Thomas. The reliability assessment methods study of PWB clean environmental materials is expected to respond to a reliability elevation and environmental material regulation policy spreading all over the world by beginning form Europe.

• Korean Journal of Clinical Pharmacy
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• v.22 no.1
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• pp.21-29
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• 2012

Modern biologics are biotechnology-derived therapeutics, including recombinant therapeutic proteins like monoclonal antibodies, cytokines and tissue growth factors. Although the pharmacokinetics of therapeutic biologics should be evaluated based on the same general principles as small molecules, careful considerations should be given to bioanalytics and pharmacokinetics when designing pharmacokinetic studies of biologics during their drug development, due to their different physicochemical properties compared with small molecules. The aim of this study was to develop a draft guidance on pharmacokinetic studies of therapeutic biologics in clinical studies. All the elements outlined in the current Food and Drug Administration (FDA), European Medicinal Agency (EMEA), and International Conference on Harmonisation (ICH) guidelines and regulations, and the related literatures previously published were searched and evaluated. In this draft guidance, the specific problems related to the pharmacokinetics of therapeutic biologics that need special consideration during drug development process were addressed, and differences in pharmacokinetic characteristics between biologics and small molecules affecting the content of the development programme were presented.