Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification (English)
- New search for: Krogulski, Sandra
- New search for: Krogulski, Sandra
In:
Therapeutic Innovation & Regulatory Science
;
51
, 5
; 645-650
;
2017
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ISSN:
- Article (Journal) / Electronic Resource
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Title:Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification
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Contributors:Krogulski, Sandra ( author )
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Published in:Therapeutic Innovation & Regulatory Science ; 51, 5 ; 645-650
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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:2017
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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 51, 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.
- 531
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DIA Then and Now: A Half-Century OdysseyTurner, J. Rick et al. | 2017
- 534
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Improving Investigative Site Contact Options on Clinical Trial Registries: Making It Easier for Patients to Find Clinical TrialsPolidori, Christa Patterson / Su, Mandy S. / Jakee, Kelsey / Hodge, Keir / Ancona, Crystal / Yoder, Joseph et al. | 2017
- 542
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Improving Information Exchange with Clinical Trial Participants: A Proposal for IndustryDietrich, Julie / Alivojvodic, Jeannine / Seliverstov, Irene / Metcalf, Marilyn / Jakee, Kelsey et al. | 2017
- 551
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Optimizing the Use of Electronic Data Sources in Clinical Trials: The Technology LandscapeKellar, Ed / Bornstein, Susan / Caban, Aleny / Crouthamel, Michelle / Celingant, Catherine / McIntire, Patricia A. / Johnson, Chrissy / Mehta, Prasann / Sikirica, Vanja / Wilson, Brett et al. | 2017
- 568
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The Case for a Bayesian Approach to Benefit-Risk Assessment: Overview and Future DirectionsCosta, Maria J. / He, Weili / Jemiai, Yannis / Zhao, Yueqin / Di Casoli, Carl et al. | 2017
- 575
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Baseline Assessment of a Global Clinical Investigator Landscape Poised for Structural ChangeGetz, Kenneth / Brown, Carrie / Stergiopoulos, Stella / Beltre, Cerdi et al. | 2017
- 582
-
Quantitative Assessment of Premium Rates for Clinical Usefulness in New Drug Price Calculation in JapanTakayama, Akane / Kobayashi, Eriko / Nakamura, Tetsuya / Narukawa, Mamoru et al. | 2017
- 589
-
Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in JapanSudo, Tomohisa / Sato, Akihiro et al. | 2017
- 597
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Drugs Targeted for Price Cutting in Japan: The Case of Price Revisions Based on the Divergence of Official Versus Delivery PricesFukumoto, Daigo / Tsuyuki, Ai / Suzuki, Takeshi et al. | 2017
- 604
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Comparison of New Drug Accessibility and Price Between Japan and Major European CountriesTakayama, Akane / Narukawa, Mamoru et al. | 2017
- 612
-
Improving Patient Involvement in Medicines Research and Development: A Practical RoadmapGeissler, Jan / Ryll, Bettina / di Priolo, Susanna Leto / Uhlenhopp, Mary et al. | 2017
- 620
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Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient MedicinesGarbe, Joerg H. O. / Jacobs, Maria G. / Rönninger, Stephan K. et al. | 2017
- 625
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On a Stepwise Quantitative Approach for Benefit-Risk AssessmentHe, Weili / Sun, Yaxuan / Li, Qing / Wan, Sabrina et al. | 2017
- 635
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The Benefit-Risk Assessment of Medicines: Experience of a Consortium of Medium-Sized Regulatory AuthoritiesMcAuslane, Neil / Leong, James / Liberti, Lawrence / Walker, Stuart et al. | 2017
- 645
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Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 SpecificationKrogulski, Sandra et al. | 2017
- 651
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Analysis of Review Times for Recent 505(b)(2) ApplicationsSakai, Sharon / DiMasi, Joseph A. / Getz, Kenneth A. et al. | 2017