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Therapeutic Innovation and Regulatory Science

Volumn 49, Issue 1, 2015, Pages 100-107

Effective Drug Supply for Adaptive Clinical Trials: Recommendations by the DIA Adaptive Design Scientific Working Group Drug Supply Subteam

(8) Burnham, Nancy a Quinlan, Judith b He, Weili c Marshall, Micheline d Nicholls, Graham e Patel, Nitin f Parke, Tom g Wong, L B h

a Hambel Statistical Consulting LLC (United States)

b SVP Innovations Center Aptiv Solutions (United States)

c MERCK RESEARCH LABORATORIES (United States)

d PFIZER INC (United States)

e Almac Sciences (United Kingdom)

f Cytel Incorporated (United States)

g Tessella Ltd ^* (United Kingdom)

h ELI LILLY AND COMPANY (United States)

Author keywords

adaptive designs; clinical trials development; drug supply

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); DRUG COST; DRUG LABELING; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SUPPLY; HUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RESOURCE ALLOCATION; STUDY DESIGN; TREATMENT PLANNING;

EID: 84920973905 PISSN: 21684790 EISSN: 21684804 Source Type: Journal
DOI: 10.1177/2168479014530968 Document Type: Article

Times cited : (2)

References (8)

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- US Food and Drug Administration, Draft Guidance for Industry: Adaptive design clinical trials for drugs and biologics. http//www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UMC201790.pdf.
- US Food and Drug Administration, Draft Guidance for Industry: Adaptive design clinical trials for drugs and biologics

2
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- Doc.ref.CHMP/EWP/2459/12
- Committee for Medicines Products for Human Use, European Medicines Agency: Reflection Paper- Confimatory Clinical Trials Planned with an Adaptive Design,.Doc.ref.CHMP/EWP/2459/12.
- Committee for Medicines Products for Human Use, European Medicines Agency: Reflection Paper- Confimatory Clinical Trials Planned with an Adaptive Design

3
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- Barriers and opportunities to the implementation of adaptive design in pharmaceutical product development
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- Quinlan, J.A.¹ Gaydos, B.² Maca, J.³ Krams, M.⁴

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- Adaptive designs: terminology and classification
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- Dragalin, V.¹

5
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- Simulation: a critical tool in adaptive
- Nicholls G,Patel N,Byron B.Simulation: a critical tool in adaptive.Appl Clin Trials. 2009;:18
- (2009) Appl Clin Trials , pp. 18
- Nicholls, G.¹ Patel, N.² Byron, B.³

6
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- MarshallMBurnhamNPatelN. Published March 2010
- MarshallMBurnhamNPatelN. Drug supply management for adaptive trials. http://biopharmnet.com/doc/doc12004-07.html. Published March 2010.
- Drug supply management for adaptive trials

7
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- Modeling, prediction and adaptive adjustment of recruitment in multicenter trials
- Anisimov V,Fedorov V.Modeling, prediction and adaptive adjustment of recruitment in multicenter trials.Stat Med. 2007;27:4958-4975
- (2007) Stat Med , vol.27 , pp. 4958-4975
- Anisimov, V.¹ Fedorov, V.²

8
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- Planning and executing response-adaptive learn-phase clinical trials: 2. Case studies
- ,,, et al.. ;:-
- Fardipour P,Littman G,Burns DD, et al.Planning and executing response-adaptive learn-phase clinical trials: 2. Case studies.Drug Info J. 2009;43:725-734
- (2009) Drug Info J , vol.43 , pp. 725-734
- Fardipour, P.¹ Littman, G.² Burns, D.D.³

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.