Relevant bibliographies by topics / Seamless phase II/III

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Seamless phase II/III'

Author: Grafiati
Published: 4 June 2021
Last updated: 18 February 2022

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Journal articles on the topic "Seamless phase II/III"

1

Stallard, Nigel, and Susan Todd. "Seamless phase II/III designs." Statistical Methods in Medical Research 20, no. 6 (2010): 623–34. http://dx.doi.org/10.1177/0962280210379035.

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In recent years, there has been a drive to save development costs and shorten time-to-market of new therapies. Research into novel trial designs to facilitate this goal has led to, amongst other approaches, the development of methodology for seamless phase II/III designs. Such designs allow treatment or dose selection at an interim analysis and comparative evaluation of efficacy with control, in the same study. Methods have gained much attention because of their potential advantages compared to conventional drug development programmes with separate trials for individual phases. In this article
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Spivack, John, Bin Cheng, and Bruce Levin. "Adding dose modifications into Phase II and Phase II/III seamless trials." Statistical Methods in Medical Research 29, no. 5 (2019): 1315–24. http://dx.doi.org/10.1177/0962280219859387.

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We present a technique for adding dose modifications into seamless Phase II and Phase II/III trials featuring dose selection at an interim analysis. The method is convenient to apply and can be used either in a fully prespecified, structured way or as a response to new considerations that emerge at interim. Strong control of the familywise error rate regarding false declarations of efficacy versus control is maintained. Two examples are given. One illustrates how the method could potentially “save” a trial performed in a Phase II context. The other is a seamless Phase II/III trial that uses an
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Wang, Lin, and Lu Cui. "Seamless Phase II/III Combination Study Through Response Adaptive Randomization." Journal of Biopharmaceutical Statistics 17, no. 6 (2007): 1177–87. http://dx.doi.org/10.1080/10543400701645322.

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Maca, Jeff, Sumon Bhattacharya, Vladimir Dragalin, Paul Gallo, and Michael Krams. "Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples." Drug Information Journal 40, no. 4 (2006): 463–73. http://dx.doi.org/10.1177/216847900604000412.

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Bischoff, Wolfgang, and Frank Miller. "A Seamless Phase II/III Design with Sample-Size Re-Estimation." Journal of Biopharmaceutical Statistics 19, no. 4 (2009): 595–609. http://dx.doi.org/10.1080/10543400902963193.

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Stallard, Nigel. "Group-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials." Journal of Biopharmaceutical Statistics 21, no. 4 (2011): 787–801. http://dx.doi.org/10.1080/10543406.2011.551335.

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Zhu, Hongjian, Jin Piao, J. Jack Lee, Feifang Hu, and Lixin Zhang. "Response adaptive randomization procedures in seamless phase II/III clinical trials." Journal of Biopharmaceutical Statistics 30, no. 1 (2019): 3–17. http://dx.doi.org/10.1080/10543406.2019.1657439.

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Quan, Hui, Xiaodong Luo, Tianyue Zhou, and Peng-Liang Zhao. "Seamless phase II/III/IIIb clinical trial designs with different endpoints for different phases." Communications in Statistics - Theory and Methods 49, no. 22 (2019): 5436–54. http://dx.doi.org/10.1080/03610926.2019.1618871.

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Rosenthal, David Ira, Qiang Zhang, Merrill S. Kies, et al. "Seamless phase II/III trial design with survival and PRO endpoints for treatment selection: Case study of RTOG 1216." Journal of Clinical Oncology 31, no. 15_suppl (2013): TPS6099. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.tps6099.

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TPS6099 Background: Clinical trial results from phase II trials to select an experimental treatment arm for separate phase III trial comparison can require years. Cancer clinical trials also now aim at both survival and PRO/functional outcomes, especially in head and neck (HN) studies. We developed a unique seamless phase II/III trial design to save on sample size and trial duration. The initial multi-arm phase II trial selects the most effective regimen among multiple experimental arms by first comparing each of the new treatments to a common control arm, using chosen endpoints, such as progr
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Hampson, Lisa V., and Christopher Jennison. "Optimizing the data combination rule for seamless phase II/III clinical trials." Statistics in Medicine 34, no. 1 (2014): 39–58. http://dx.doi.org/10.1002/sim.6316.

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Dissertations / Theses on the topic "Seamless phase II/III"

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Kimani, Peter Kung'u. "Dose selection in seamless phase II/III clinical trials based on efficacy and toxicity." Thesis, University of Warwick, 2009. http://wrap.warwick.ac.uk/2765/.

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Seamless phase II/III clinical trials are attractive in development of new drugs because they accelerate the drug development process. Seamless phase II/III trials are carried out in two stages. After stage 1 (phase II stage), an interim analysis is performed and a decision is made on whether to proceed to stage 2 (phase III stage). If the decision is to continue with further testing, some dose selection procedure is used to determine the set of doses to be tested in stage 2. Methodology exists for the analysis of such trials that allows complete flexibility of the choice of doses that continu
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Aouni, Jihane. "Utility-based optimization of phase II / phase III clinical development." Thesis, Montpellier, 2019. http://www.theses.fr/2019MONTS032/document.

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Le développement majeur de la thèse a été consacré au problème d’optimisation du choix de dose dans les essais de recherche de dose, en phase II. Nous avons considéré ce problème sous l’angle des fonctions d’utilité. Nous avons alloué une valeur d’utilité aux doses, le problème pour le sponsor étant de trouver la meilleure dose, c’est-à-dire celle dont l’utilité est la plus élevée.Dans ce travail, nous nous sommes limités à une seule fonction d’utilité, intégrant deux composantes: une composante liée à l’efficacité (la POS=puissance d’un essai de phase III de 1000 patients de cette dose contre
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Ayanlowo, Ayanbola Olajumoke. "Examination of novel statistical designs for phase II and phase III clinical trials." Thesis, Birmingham, Ala. : University of Alabama at Birmingham, 2007. https://www.mhsl.uab.edu/dt/2008r/ayanlowo-ayanbola.pdf.

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Arce, Dennis, Reynaldo Garza, and Thomas McAndrews. "Enhanced Flight Termination System Study - Phase II and III Status." International Foundation for Telemetering, 2001. http://hdl.handle.net/10150/606407.

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International Telemetering Conference Proceedings / October 22-25, 2001 / Riviera Hotel and Convention Center, Las Vegas, Nevada<br>The Range Commanders Council (RCC) Range Safety Group (RSG) is conducting a study into the next generation of ground-based flight termination technology, known as the Enhanced Flight Termination System (EFTS) study. The study was initiated by the RCC in April 2000 with a scheduled completion of March 2002. The Government is performing the study with support from contractors and academia. This paper will discuss specific details of phase II and III of the EFTS
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Mansour, Vladimir. "Essai de phase II de chimiothérapie intrapéritonéale dans les carcinomes ovariens aux stades III et IV." Caen, 1990. http://www.theses.fr/1990CAEN3106.

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Nkabyo, Henry Ane. "A study on the reversible photo-induced isomerisation of platinum(II) and palladium(II) complexes of the N,N-dialkyl-N’-acyl(aroyl)thioureas with reversed-phase HPLC separation from related rhodium(III), ruthenium(III) and iridium(III) complexes." Thesis, Stellenbosch : Stellenbosch University, 2014. http://hdl.handle.net/10019.1/86773.

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Hanet, Nathalie. "Effets de perturbateurs endocriniens d'origine alimentaire sur les enzymes de phase II et les transporteurs de phase III impliqués dans le métabolisme de l'oestradiol." Dijon, 2007. http://www.theses.fr/2007DIJOPE01.

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Bork, Ines. "Phase-II-Studie zur Behandlung des nicht kleinzelligen Bronchialkarzinoms im Stadium III b und IV mit der Kombination Docetaxel und Carboplatin." [S.l.] : [s.n.], 2003. http://deposit.ddb.de/cgi-bin/dokserv?idn=970941560.

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Bauer, Katja [Verfasser], and Stefan [Gutachter] Knop. "Langzeit-Nachbeobachtung von Patienten aus einer Phase III-Studie zum Vergleich zweier Hochdosischemotherapie-Protokolle bei Patienten mit multiplem Myelom im Stadium II/III („DSMM I“-Studie) / Katja Bauer. Gutachter: Stefan Knop." Würzburg : Universität Würzburg, 2014. http://d-nb.info/1102828637/34.

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Hérold, Claire. "Recherches sur la réduction des composés d'insertion du graphite avec les chlorures de fer III et de cobalt II par les métaux alcalins lourds en phase vapeur." Nancy 1, 1991. http://docnum.univ-lorraine.fr/public/SCD_T_1991_0068_HEROLD.pdf.

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La première partie est une analyse des travaux antérieurs (une centaine) qui sont résumés dans des tableaux récapitulatifs. Le travail expérimental consiste en la réduction du trichlorure de fer et du déchlorure de cobalt insérés dans le graphite. Ces composés ont été complètement réduits par les métaux alcalins lourds en phase vapeur entre 100 et 300. L'emploi d'un graphite précurseur formé de particules monocristallines (diamètre moyen 10, épaisseur inferieure à 0,1 micron) facilement orientables sur un support plan, et l'association de techniques variées ont permis la description des produi
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Books on the topic "Seamless phase II/III"

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Phase II study Ipuh (Seblat) II E: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Phase II study Manna X/F: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Associates, Halcrow Fox and. Phase II study Babat XVI/H: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Phase II study Bintuhan XI/E: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Phase II study Peninjauan XIb/J: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Phase II study Benakat VI/E: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, 1987.

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Phase II study Kelingi IV/E: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Screening (phase II) feasibility studies and detailed engineering (phase III) for transmigration settlements development, Central Kalimantan: Phase II report, screening WPP III Teweh Timur, SKP D. Government of Indonesia, Dept. of Public Works, Directorate General of Cipta Karya, Directorate of City and Regional Planning, 1988.

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Phase II study Bayung Lincir XXV/A: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Associates, Halcrow Fox and. Phase II study Bingin Teluk I/I: Phase II studies, phase III A studies and technical assistance for transmigration settlement development. Govt. of Indonesia, Ministry of Transmigration, Directorate General of Settlement Preparation, Direktorat Bina Program, 1987.

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Book chapters on the topic "Seamless phase II/III"

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Shih, Weichung Joe, and Joseph Aisner. "Seamless Phase II/III: Select-the-Winner Design." In Statistical Design, Monitoring, and Analysis of Clinical Trials, 2nd ed. Chapman and Hall/CRC, 2021. http://dx.doi.org/10.1201/9781003176527-13.

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Li, Pei, Yanli Zhao, Xiao Sun, and Ivan S. F. Chan. "Multiplicity Adjustment in Seamless Phase II/III Adaptive Trials Using Biomarkers for Dose Selection." In ICSA Book Series in Statistics. Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-12694-4_17.

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Liu, Qing. "Phase II/III Trials." In Methods and Applications of Statistics in Clinical Trials. John Wiley & Sons, Inc., 2014. http://dx.doi.org/10.1002/9781118596005.ch55.

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Fox, Anthony W. "Phase II and Phase III Clinical Studies." In Principles and Practice of Pharmaceutical Medicine. Wiley-Blackwell, 2010. http://dx.doi.org/10.1002/9781444325263.ch10.

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Alex, Alexander, C. John Harris, Wilma W. Keighley, and Dennis A. Smith. "Compound Attrition in Phase II/III." In Attrition in the Pharmaceutical Industry. John Wiley & Sons, Inc, 2015. http://dx.doi.org/10.1002/9781118819586.ch4.

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Ting, Naitee, Ding-Geng Chen, Shuyen Ho, and Joseph C. Cappelleri. "Overview of Phase III Clinical Trials." In Phase II Clinical Development of New Drugs. Springer Singapore, 2017. http://dx.doi.org/10.1007/978-981-10-4194-5_12.

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Meier-Lenschow, Th, B. P. E. Clasen, P. Lukas, and Ch Hasenau. "Simultane Radiochemotherapie fortgeschrittener Kopf-Hals-Malignome — Eine Phase-III-Studie." In Teil II: Sitzungsbericht. Springer Berlin Heidelberg, 1989. http://dx.doi.org/10.1007/978-3-642-83931-3_57.

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Coates, Anthony R. M., and Gerry Halls. "Antibiotics in Phase II and III Clinical Trials." In Handbook of Experimental Pharmacology. Springer Berlin Heidelberg, 2012. http://dx.doi.org/10.1007/978-3-642-28951-4_11.

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Hönerlage, B. "AgI: phase transitions, p-T phase diagram." In New Data and Updates for III-V, II-VI and I-VII Compounds. Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-540-92140-0_35.

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Hönerlage, B. "CuI: phase transitions, p-T phase diagram." In New Data and Updates for III-V, II-VI and I-VII Compounds. Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-540-92140-0_263.

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Conference papers on the topic "Seamless phase II/III"

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Zhao, Guopeng, Xinwei Zhou, Chao Jiang, Yi Lu, and Yanjie Wang. "Inductance parameter design based seamless transfer strategy for three-phase converter in microgrid." In MATERIALS SCIENCE, ENERGY TECHNOLOGY AND POWER ENGINEERING II (MEP2018). Author(s), 2018. http://dx.doi.org/10.1063/1.5041150.

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Marines-Garcia, Israel, Mauricio Pelcastre, Enrique Garcia, et al. "Fatigue Strength of Heavy Wall Line Pipe Girth Weld for J-Lay Installation." In ASME 2018 37th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/omae2018-78056.

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Tenaris and ExxonMobil conducted a qualification program focused on Heavy Wall Seamless Line Pipe (HW SMLS LP) and its girth welds, to experimentally demonstrate and validate the material potential to be used as riser or fatigue sensitive flowline for the development of challenging deep and ultra-deep offshore fields. The qualification program was divided in three phases. Phase I [1] included: 1) HW SMLS LP, X65QS, 273 mm OD, 46 mm WT plain pipe qualification; and 2) development and qualification of a WPS (STT® process for root pass and GMAW process for hot, fill &amp; cap passes, narrow groov
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Riestenberg, David. "SECARB Phase II and Phase III." In Carbon Storage Project Review Meeting Virtual September 2020. US DOE, 2020. http://dx.doi.org/10.2172/1749863.

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Wood, J., Josh Collins, Kyle Wilson, et al. "Advanced Stirling Convertor Phase II Achievements and Planned Phase III Efforts." In 4th International Energy Conversion Engineering Conference and Exhibit (IECEC). American Institute of Aeronautics and Astronautics, 2006. http://dx.doi.org/10.2514/6.2006-4108.

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Freese, Katherine, Paolo Gondolo, and Douglas Spolyar. "The Effect of Dark Matter on the First Stars: A New Phase of Stellar Evolution." In FIRST STARS III: First Stars II Conference. American Institute of Physics, 2008. http://dx.doi.org/10.1063/1.2905656.

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Silva, Milto, Iaralice Souza, Renata Bastos, et al. "Thermostability Study of Meningococcal Conjugate Bulks produced for phase III clinical trials." In II Seminário Anual Científico e Tecnológico em Imunobiológicos. Instituto de Tecnologia em Imunobiológicos, 2014. http://dx.doi.org/10.35259/isi.sact.2014_26535.

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Prater, Tracie, Tony Kim, Monsi C. Roman, and Robert P. Mueller. "NASAÕs Centennial Challenge for 3D-Printed Habitat: Phase II Outcomes and Phase III Competition Overview." In 2018 AIAA SPACE and Astronautics Forum and Exposition. American Institute of Aeronautics and Astronautics, 2018. http://dx.doi.org/10.2514/6.2018-5405.

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Brown, Eric N. "Shock and Recovery of Polytetrafluoroethylene Above and Below the Phase II to Phase III Transition." In SHOCK COMPRESSION OF CONDENSED MATTER - 2005: Proceedings of the Conference of the American Physical Society Topical Group on Shock Compression of Condensed Matter. AIP, 2006. http://dx.doi.org/10.1063/1.2263297.

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Laws, Burt A., and Sandra L. Foerg. "Early Human Testing of Advanced Life Support Systems, Phase II and III." In International Conference on Environmental Systems. SAE International, 1995. http://dx.doi.org/10.4271/951491.

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KUROKAWA, SHIN-ICHI. "ELECTRON-POSITRON COLLIDER B-FACTORIES PEP-II, KEKB AND CESR PHASE III." In Proceedings of the 2nd International Conference. WORLD SCIENTIFIC, 1998. http://dx.doi.org/10.1142/9789814503952_0001.

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Reports on the topic "Seamless phase II/III"

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Roy Crooks, Ph D. ,. P. E. Production of Seamless Superconducting Radio Frequency Cavities from Ultra-fine Grained Niobium, Phase II Final Report. Office of Scientific and Technical Information (OSTI), 2009. http://dx.doi.org/10.2172/967061.

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Author, Not Given. Phase I (CATTS Theory), Phase II (Milne Point), Phase III (Hydrate Ridge). Office of Scientific and Technical Information (OSTI), 2009. http://dx.doi.org/10.2172/1060006.

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Pawel, J. E., K. E. Lenox, and I. Ioka. Status of DOE/JAERI collaborative program phase II and phase III capsules. Office of Scientific and Technical Information (OSTI), 1996. http://dx.doi.org/10.2172/270467.

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Robertson, J. P., K. E. Lenox, I. Ioka, and E. Wakai. Status of DOE/JAERI collaborative program phase II and phase III capsules. Office of Scientific and Technical Information (OSTI), 1997. http://dx.doi.org/10.2172/543306.

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Figueroa, Victor G., Douglas J. Ammerman, Carlos Lopez, and Walter Gill. Pipe Overpack Container Fire Testing: Phase I II & III. Office of Scientific and Technical Information (OSTI), 2018. http://dx.doi.org/10.2172/1422355.

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Cilke, John F., Raymond C. Parks, Donald Ray Funkhouser, et al. The role of technology in reducing health care costs. Phase II and phase III. Office of Scientific and Technical Information (OSTI), 2004. http://dx.doi.org/10.2172/970293.

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Lawrence, Christopher A., Richard C. Anderson, and Jr. Capture Rate Study, Phase III, Post-World War II Capture Rates. Defense Technical Information Center, 2000. http://dx.doi.org/10.21236/ada401064.

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Miller, R. O., and G. B. J. Fader. Cruise report 88-018[B] Phase II; 88-018[B] Phase III, F.R.V. Navicula, Yarmouth, south - Yarmouth, north, June 5th - June 17th, 1988. Natural Resources Canada/ESS/Scientific and Technical Publishing Services, 1989. http://dx.doi.org/10.4095/130793.

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Griffith, G. W., and H. O. Menlove. Design study for MOX fuel rod scanner for ATR fuel fabrication. Phase I: Design of active neutron scanner. Phase II: Design of passive neutron scanner. Phase III: Design of passive gamma-ray scanner. Office of Scientific and Technical Information (OSTI), 1997. http://dx.doi.org/10.2172/534497.

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Ferris, F. Grant, and Eric Roden. Microbial Mineral Transformations at the Fe(II)/Fe(III) Redox Boundary for Solid Phase Capture of Strontium and Other Metal/Radionuclide Contaminants. Office of Scientific and Technical Information (OSTI), 1999. http://dx.doi.org/10.2172/827181.

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