주요국의 의약품 사전상담제도 현황과 정책적 함의 = Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences
| DC Field | Value |
|---|---|
| dc.contributor.author | 박실비아 |
| dc.contributor.author | 박은자 |
| dc.contributor.author | 한현진 |
| dc.date.accessioned | 2017-01-25T04:13:07Z |
| dc.date.available | 2017-01-25T04:13:07Z |
| dc.date.issued | 2008-06-30 |
| dc.identifier.issn | 0513-4242 |
| dc.identifier.uri | https://repository.kihasa.re.kr/handle/201002/25283 |
| dc.description.abstract | Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations. |
| dc.format.extent | 9 |
| dc.language | kor |
| dc.publisher | 대한약학회 |
| dc.title | 주요국의 의약품 사전상담제도 현황과 정책적 함의 |
| dc.title.alternative | Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences |
| dc.type | Article |
| dc.type.local | Article(Academic) |
| dc.identifier.apprname | 학술논문평가 |
| dc.subject.keyword | pharmaceutical |
| dc.subject.keyword | consultation |
| dc.subject.keyword | pre-submission |
| dc.subject.keyword | research |
| dc.subject.keyword | development |
| dc.contributor.affiliatedAuthor | 박실비아 |
| dc.contributor.affiliatedAuthor | 박은자 |
| dc.identifier.url | http://www.yakhak.org/journal/view.html?uid=2435&page=&sort=&scale=10&all_k=&s_t=onsultation+Program+for+Pharmaceutical+Development-Lessons+from+Foreign+Countries&s_a=&s_k=&s_v=&s_n=&spage=&pn=search&year=&vmd=Full |
| dc.citation.title | 약학회지 |
| dc.citation.volume | 52 |
| dc.citation.number | 2 |
| dc.citation.startPage | 151 |
| dc.citation.endPage | 159 |
| dc.identifier.bibliographicCitation | 약학회지, vol. 52, no. 2, pp. 151 - 159 |
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