Regulation of New Drug Approval in Taiwan (English)
- New search for: Yang, Ya-Ting
- New search for: Huang, Hsiau-Wen
- New search for: Chen, Ya-Ting
- New search for: Chiang, Yu-Mei
- New search for: Tzou, Meir-Chyun
- New search for: Yang, Ya-Ting
- New search for: Huang, Hsiau-Wen
- New search for: Chen, Ya-Ting
- New search for: Chiang, Yu-Mei
- New search for: Tzou, Meir-Chyun
In:
Therapeutic Innovation & Regulatory Science
;
50
, 5
; 602-608
;
2016
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Regulation of New Drug Approval in Taiwan
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Contributors:Yang, Ya-Ting ( author ) / Huang, Hsiau-Wen ( author ) / Chen, Ya-Ting ( author ) / Chiang, Yu-Mei ( author ) / Tzou, Meir-Chyun ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 50, 5 ; 602-608
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Publisher:
- New search for: Springer International Publishing
- New search for: Springer Nature
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Place of publication:[New York]
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Publication date:2016
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ISSN:
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ZDBID:
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DOI:
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Type of media:Article (Journal)
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Type of material:Electronic Resource
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Language:English
- New search for: 44.38
- Further information on Basic classification
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Keywords:
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Classification:
BKL: 44.38 Pharmakologie -
Source:
Table of contents – Volume 50, Issue 5
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 529
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Progress on Behalf of ChildrenSpielberg, Stephen P. et al. | 2016
- 530
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TransCelerate’s Clinical Quality Management System: Issue ManagementCallery-D’Amico, Susan / Sam, Leslie M. / Grey, Timothy H. / Greenwood, Daniel J. et al. | 2016
- 536
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A Knowledge Management Framework and Approach for Clinical DevelopmentSalzano, Kathy A. / Maurer, Christa A. / Wyvratt, Jean M. / Stewart, Terry / Peck, Jennifer / Rygiel, Beata / Petree, Teresa et al. | 2016
- 546
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Patient Engagement at a Tipping Point—The Need for Cultural Change Across Patient, Sponsor, and Regulator Stakeholders: Insights From the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle of Medical Products”Smith, Meredith Y. / Hammad, Tarek A. / Metcalf, Marilyn / Levitan, Bennett / Noel, Rebecca / Wolka, Anne M. / Michaels, Debra L. / Johnson, F. Reed et al. | 2016
- 554
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A Theory on the Relativity of Factors Impacting the Utilization of Medical Information Services From the Pharmaceutical IndustryAlbano, Dominick / Soloff, Allison / Heim, Katelyn / Mavila, Sudeep et al. | 2016
- 560
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Improving Information Processing: The Effect of Label Format Among Current and Potential Over-the-Counter Medication UsersBhansali, Archita H. / Fleming, Marc L. / Sherer, Jefferey T. / Sansgiry, Sujit S. et al. | 2016
- 569
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Survey of Health Care Practitioners’ Preferences for Medical Information: Collective Insights for Impacting Patient CareFung, Stacey M. / Chang, Dannis Y. / Patel-Romero, Roshni / Suchodolski, Matt et al. | 2016
- 577
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A Patient Centricity Team Tool to Enable Patient-Focused Drug DevelopmentAshkenazy, Rebecca / Schneider, Roslyn F. et al. | 2016
- 581
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Do Patients Use a Headline Section in a Leaflet to Find Key Information About Their Medicines? Findings From a User-Test StudyDickinson, Rebecca / Raynor, David K. / Knapp, Peter / MacDonald, Jan et al. | 2016
- 592
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The Early Engagement Model in Product Development: Linking “Proof of Concept” to “Proof of Medical Value”Iqbal, Sheikh Usman / Salimi, Tehseen / Dunlop, John / Paramore, L. Clark et al. | 2016
- 602
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Regulation of New Drug Approval in TaiwanYang, Ya-Ting / Huang, Hsiau-Wen / Chen, Ya-Ting / Chiang, Yu-Mei / Tzou, Meir-Chyun et al. | 2016
- 609
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Attitudes Toward Clinical Trials Among Physicians in China With Different Levels of ExperienceZheng, Hang / Wang, Liqing / Wu, Hongyan / Wang, Miao / Sun, He et al. | 2016
- 615
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The Impact of Adaptive Design on Portfolio OptimizationAntonijevic, Zoran et al. | 2016
- 620
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Pragmatic Multicriteria Decision Analysis (MCDA) Combined With Advanced Pharmacoepidemiology for Benefit-Risk Assessments of Medicines Adapted to the Real-Life Constraints of Regulators: Development and Case StudyGoetghebeur, Mireille M. / Wagner, Monika / Nikodem, Mateusz / Zyla, Agnieszka / Micaleff, Alain / Amzal, Billy et al. | 2016
- 632
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Nonclinical Safety Considerations for the Development of Pediatric-First Drugs: An Industry ViewSchmitt, G. / Ridings, J. / De Schaepdrijver, L. / van Doesum-Wolters, F. L. C. / Cappon, G. D. / Hartmann, A. et al. | 2016
- 639
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A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007–2013Egger, Gunter F. / Wharton, Gerold T. / Malli, Suzanne / Temeck, Jean / Murphy, M. Dianne / Tomasi, Paolo et al. | 2016
- 648
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Responsibilities of Data Monitoring Committees: Consensus RecommendationsBierer, Barbara E. / Li, Rebecca / Seltzer, Jonathan / Sleeper, Lynn A. / Frank, Elizabeth / Knirsch, Charles / Aldinger, Carmen E. / Levine, Robert J. / Massaro, Joe / Shah, Amish et al. | 2016
- 660
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Product Development Under FDA’s Animal Rule: Understanding FDA’s Expectations and Potential Implications for Traditional Development ProgramsAllio, Theresa et al. | 2016