作者：Daniel S. Hsieh (1)
Hongfei Yue (2)
Sarah J. Nicholson (3)
Daniel Roberts (1)
Richard Schild (4)
John F. Gamble (3)
Mark Lindrud (4)

1. Drug Product Science & Technology ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; New Jersey ; 08903 ; USA
2. Analytical and Bioanalytical Development ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; New Jersey ; 08903 ; USA
3. Drug Product Science & Technology ; Bristol-Myers Squibb Company ; Reeds Lane ; Moreton ; Merseyside ; CH46 1QW ; UK
4. Chemical Development ; Bristol-Myers Squibb Company ; One Squibb Drive ; New Brunswick ; NJ ; 08903 ; USA

关键词：amorphous ; Fickian diffusion ; modeling ; secondary drying ; spray dried dispersion

刊名：Pharmaceutical Research

出版年：2015

作者：Xianying Pan (1)
Teresa A. Simon (2)
Melissa Hamilton (3)
Andreas Kuznik (4)

1. Global Health Economics and Outcomes Research ; Bristol-Myers Squibb Company ; 5 Research Parkway ; Wallingford ; CT ; 06492 ; USA
2. Global Pharmacovigilence and Epidemiology ; Bristol-Myers Squibb Company ; Hopewell ; NJ ; 08534 ; USA
3. Global Health Economics and Outcomes Research ; Bristol-Myers Squibb Company ; 100 Nassau Park Boulevard ; 3.NN37 ; Princeton ; NJ ; 08543 ; USA
4. Department of Pricing and Market Access ; Celgene Corporation ; 33 Technology Drive ; Warren ; NJ ; 07059 ; USA

关键词：Atrial fibrillation ; Hemorrhagic stroke ; Ischemic stroke ; Patient outcomes

刊名：Journal of Thrombosis and Thrombolysis

出版年：2015

作者：Jinjiang Li (1)
Junshu Zhao (1)
Li Tao (1)
Jennifer Wang (1) (3)
Vrushali Waknis (1)
Duohai Pan (1)
Mario Hubert (2)
Krishnaswamy Raghavan (1)
Jatin Patel (1)

1. Drug Product Science and Technology ; Bristol-Myers Squibb ; New Brunswick ; NJ ; USA
3. Teva Pharmaceuticals ; North Wales ; PA ; 19454 ; USA
2. Analytical and Bioanalytical Development ; Bristol-Myers Squibb ; New Brunswick ; NJ ; USA

关键词：amorphous dispersions ; chain rigidity and solution comformation ; free volume by PALS ; glass transition ; polymeric excipients ; cellulose derivatives and ployvinyl polymers

刊名：Pharmaceutical Research

出版年：2015

作者：Claudia C. Corredor (1)
Ruben Lozano (1)
Xin Bu (1)
Ryan McCann (2)
Jeffrey Dougherty (3)
Tim Stevens (1)
Douglas Both (1)
Pankaj Shah (1)

1. Biopharmaceutics Process Analytical Sciences (BPAS) ; Analytical and Bioanalytical Development ; Bristol-Myers Squibb ; New Brunswick ; NJ ; 08901 ; USA
2. Global Manufacturing & Supply ; Bristol-Myers Squibb ; Mt. Vernon ; IN ; 47620 ; USA
3. Drug Product Science and Technology ; Bristol-Myers Squibb ; New Brunswick ; NJ ; 08901 ; USA

关键词：Analytical method quality by design ; Control strategy ; NIR blending method ; Design of experiments ; Chemometrics

刊名：Journal of Pharmaceutical Innovation

出版年：2015

作者：James Bergum (1)
Thomas Parks (2)
James Prescott (3)
Ravindra Tejwani (4)
Jon Clark (6)
William Brown (6)
Fernando Muzzio (8)
Samir Patel (5)
Charles Hoiberg (7)

1. BergumSTATS ; Howell ; NJ ; USA
2. Eli Lilly and Company ; Indianapolis ; IN ; USA
3. Jenike and Johanson ; Inc. ; Tyngsboro ; MA ; USA
4. Bristol-Myers Squibb Company Research and Development ; New Brunswick ; NJ ; USA
6. United States Pharmacopeia-National Formulary ; Rockville ; MD ; USA
8. Rutgers University ; New Brunswick ; NJ ; USA
5. Teva Pharmaceuticals ; North Wales ; PA ; USA
7. Pfizer Inc. ; Silver Springs ; MD ; USA

关键词：Content uniformity ; ASTM E2709/E2810 ; Statistical sampling plans ; USP General Chapter < ; 905> ; Uniformity of Dosage Units ; Guidance for Industry ; Process Validation

刊名：Journal of Pharmaceutical Innovation

出版年：2015

作者：P. P. Peethambaram (1)
L. C. Hartmann (1)
D. J. Jonker (3)
M. de Jonge (6)
E. R. Plummer (4)
L. Martin (2)
J. Konner (5)
J. Marshall (7)
G. D. Goss (3)
V. Teslenko (8)
P. L. Clemens (8)
L. J. Cohen (8)
C. M. Ahlers (8)
L. Alland (8) (9)

1. Mayo Clinic Cancer Center ; Rochester ; MN ; USA
3. The Ottawa Hospital Cancer Centre ; Ottawa ; ON ; Canada
6. Erasmus MC-Daniel den Hoek Kliniek ; Rotterdam ; The Netherlands
4. The Northern Centre for Cancer Care ; Newcastle upon Tyne ; United Kingdom
2. Fox Chase Cancer Center ; Philadelphia ; PA ; USA
5. Memorial Sloan-Kettering Cancer Center ; New York ; NY ; USA
7. Georgetown University ; Georgetown ; Washington D.C. ; USA
8. Bristol-Myers Squibb Research and Development ; Princeton ; NJ ; USA
9. AstraZeneca Pharmaceuticals ; 35 Gatehouse Drive ; Waltham ; MA ; 02451 ; USA

关键词：Folate conjugate ; Epothilone ; Phase I trial ; Advanced cancer

刊名：Investigational New Drugs

出版年：2015

作者：Christopher Evans (1)
Mark Arnold (2)
Peter Bryan (3)
Jeffrey Duggan (4)
Christopher A James (5)
Wenkui Li (6)
Steve Lowes (7)
Luca Matassa (8)
Timothy Olah (9)
Philip Timmerman (10)
Xiaomin Wang (11)
Enaksha Wickremsinhe (12)
John Williams (13)
Eric Woolf (14)
Patricia Zane (15)

1. Bioanalytical Science and Toxicokinetics (BST) ; PTS-DMPK ; GlaxoSmithKline ; 709 Swedeland Road ; King of Prussia ; PA ; 19406 ; USA
2. Bioanalytical Sciences and Selective Integration ; Bristol-Myers Squibb ; Princeton ; NJ ; 08543 ; USA
3. B2S Consulting ; Mendham ; NJ ; 07945 ; USA
4. Bioanalysis and Metabolite Profiling ; Boehringer-Ingelheim Pharmaceuticals Inc. ; Ridgefield ; CT ; 06877 ; USA
5. Bioanalytical Sciences ; PKDM ; Amgen ; Thousand Oaks ; CA ; 91320 ; USA
6. DMPK/Early Bioanalytics & Technology (EBT) ; Novartis Institutes for BioMedical Research ; East Hanover ; NJ ; 07936 ; USA
7. Bioanalytical and ADME Labs ; Quintiles ; Ithaca ; NY ; 14850 ; USA
8. Bioanalytical QPS ; LLC ; Newark ; DE ; USA
9. Bioanalytical Research ; Bristol-Myers Squibb ; Princeton ; NJ ; USA
10. Janssen Research & Development ; Beerse ; Belgium ; 2340
11. Bioanalysis ; DMPK ; Celgene Corporation ; Summit ; NJ ; 07901 ; USA
12. Lilly Research Laboratories ; Eli Lilly and Company ; Indianapolis ; IN ; 46285 ; USA
13. Drug Metabolism and Pharmacokinetics ; Vertex Pharmaceuticals Inc. ; Boston ; MA ; 02210 ; USA
14. PPDM Global Bioanalytics ; Merck and Company ; West Point ; PA ; 19486 ; USA
15. Drug Disposition ; Safety ; and Animal Research (DSAR) ; Sanofi U.S. ; Bridgewater ; NJ ; 08807 ; USA

刊名：The AAPS Journal

出版年：2015

作者：Georgina V Long (90)
Victoria Atkinson (91)
Paolo A Ascierto (92)
Benjamin Brady (93)
Caroline Dutriaux (94)
Michele Maio (95)
Laurent Mortier (96)
Jessica C Hassel (97)
Piotr Rutkowski (98)
Catriona McNeil (99)
Ewa Kalinka-Warzocha (100)
Kerry J Savage (101)
Micaela Hernberg (102)
Celeste Lebb茅 (103)
Julie Charles (104)
Catalin Mihalcioiu (105)
Vanna Chiarion-Sileni (106)
Cornelia Mauch (107)
Henrik Schmidt (108)
Dirk Schadendorf (109)
Helen Gogas (110)
Christine Horak (111)
Brian Sharkey (112)
Ian M Waxman (111)
Caroline Robert (113)

90. Melanoma Institute Australia ; University of Sydney ; and Mater Hospital ; Sydney ; Australia
91. Princess Alexandra Hospital ; Wooloongabba & Gallipoli Medical Research Foundation ; Greenslopes Private Hospital ; Queensland ; Australia
92. Istituto Nazionale Tumori Fondazione Pascale ; Naples ; Italy
93. Cabrini Health ; Melbourne ; Australia
94. H么pital Saint Andr茅 CHU ; Bordeaux ; France
95. University Hospital of Siena ; Siena ; Italy
96. H么pital Claude Huriez ; Lille ; France
97. University Hospital Heidelberg & National Center for Tumor Diseases ; Heidelberg ; Germany
98. Maria Sklodowska-Curie Memorial Cancer Center & Institute of Oncology ; Warsaw ; Poland
99. Chris O鈥橞rien Lifehouse ; The Melanoma Institute Australia & Royal Prince Alfred Hospital ; Camperdown ; Australia
100. Wojewodzki Szpital Specjalistyczny im. M. Kopernika ; Lodz ; Poland
101. British Columbia Cancer Agency ; Vancouver ; Canada ; Canada
102. Department of Oncology ; Helsinki University Central Hospital ; Helsinki ; Finland
103. APHP Dermatology and CIC H么pital Saint Louis Paris 7 University ; INSERM 976 ; Paris ; France
104. Grenoble University Hospital Grenoble France - INSERM U823 ; Joseph Fourier University ; Grenoble ; France
105. Royal Victoria Hospital ; Alberta ; Canada
106. Oncology Institute of Veneto IRCCS ; Padua ; Italy
107. Department of Dermatology ; University Hospital Cologne and CIO K枚ln ; Bonn ; Germany
108. Department of Oncology ; Aarhus University Hospital ; Aarhus ; Denmark
109. Department of Dermatology ; University of Essen ; Essen ; Germany
110. University of Athens Medical School ; Laiko General Hospital ; Athens ; Greece
111. Bristol-Myers Squibb ; Lawrenceville ; NJ ; USA
112. Bristol-Myers Squibb ; Wallingford ; CT ; USA
113. Gustave ; Roussy and INSERM U981 ; Villejuif-Paris-Sud ; France

刊名：Journal of Translational Medicine

出版年：2015

作者：Sowmya Ravi (1)
Kristen Spencer (2)
Mary Ruisi (3)
Nageatte Ibrahim (4)
Jason J Luke (5)
John A Thompson (6)
Keisuke Shirai (7)
David Lawson (8)
Heddy Bartell (9)
Ragini Kudchadkar (8)
Ngoc Thi Gunter (8)
Janice M Mehnert (2)
Evan J Lipson (1)

1. The Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center ; 1550 Orleans St. ; Rm. 507 ; Baltimore ; MD ; 21287 ; USA
2. Rutgers Cancer Institute of New Jersey ; 195 Little Albany Street ; New Brunswick ; NJ ; 08901 ; USA
3. Bristol-Myers Squibb ; Oncology Global Clinical Research ; Route 206 and Provinceline Road ; Princeton ; NJ ; 08543 ; USA
4. Dana-Farber Cancer Institute Melanoma Disease Center ; Harvard Medical School ; 450 Brookline Ave ; Boston ; MA ; 02215 ; USA
5. Dana-Farber Cancer Institute Melanoma Disease Center ; Center for ImmunoOncology ; Harvard Medical School ; 450 Brookline Ave ; Boston ; MA ; 02215 ; USA
6. Seattle Cancer Care Alliance ; University of Washington ; 825 Eastlake Ave. East ; Seattle ; WA ; 98109 ; USA
7. Division of Hematology/Oncology ; Medical University of South Carolina ; 173 Ashley Ave. ; Basic Science Building ; Suite 102 ; Charleston ; SC ; 29425 ; USA
8. The Winship Cancer Institute of Emory University School of Medicine ; 1365C Clifton Road ; Atlanta ; Georgia ; 30322 ; USA
9. Bristol-Myers Squibb. Oncology Medical Strategy ; 777 Scudders Mill Road ; Plainsboro ; NJ ; 08536 ; USA

关键词：Ipilimumab ; Melanoma ; Hepatitis B ; Hepatitis C

刊名：Journal for Immunotherapy of Cancer

出版年：2014

作者：Péter Reményi (1)
László Gopcsa (1)
Imelda Marton (2)
Marienn Réti (1)
Gábor Mikala (1)
Mónika Pet? (1)
Anikó Barta (1)
árpád Bátai (1)
Zita Farkas (1)
Zita Borbényi (2)
Zoltán Csukly (1)
Imre Bodó (1)
János Fábián (1)
ágnes Király (1)
Lilla Lengyel (1)
Klára Piukovics (2)
éva Torbágyi (1)
Tamás Masszi (1) (3)

关键词：Autologous stem cell transplantation ; Biosimilar rhG ; CSF ; Engraftment ; Hematology ; Neutropenia ; Oncology ; Peripheral blood stem cell mobilization

刊名：Advances in Therapy

出版年：2014