Genentech: Publications

January 1, 2013

Prediction of drug terminal half-life and terminal volume of distribution after intravenous dosing based on drug clearance, steady-state volume of distribution, and physiological parameters of the body

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Leonid M. Berezhkovskiy

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January 1, 2013

An alternative approach for quantitative bioanalysis using diluted blood to profile oral exposure of small molecule anticancer drugs in mice

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Bianca M. Liederer; Leonid M. Berezhkovskiy; Savita Ubhayakar; Yuzhong Deng

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January 1, 2013

CDKN2B-AS1 genotype-glaucoma feature correlations in primary open-angle glaucoma patients from the United States

American Journal of Ophthalmology, ISSN: 18791891 00029394

Louis R. Pasquale; Stephanie J. Loomis; Jae H. Kang; Brian L. Yaspan; Wael Abdrabou; Donald L. Budenz; Teresa C. Chen; Elizabeth Delbono; Friedman; Douglas Gaasterland; Terry Gaasterland; Cynthia L. Grosskreutz; Richard K. Lee; Paul R. Lichter; Yutao Liu; Catherine A. McCarty; Sayoko E. Moroi; Olson; Tony Realini; Douglas J. Rhee; Schuman; Kuldev Singh; Douglas Vollrath; Gadi Wollstein; Donald J. Zack; R. Rand Allingham; Brian W. Kunkle; Robert N. Weinreb; Kang Zhang; Michael A. Hauser; Julia E. Richards; Jonathan L. Haines; Janey L. Wiggs

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January 1, 2013

Compatibility and stability of pertuzumab and trastuzumab admixtures in i.v. infusion bags for coadministration

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Zephania Kwong Glover; Lynn Gennaro; Sandeep Yadav; Barthélemy Demeule; Wong; Alavattam Sreedhara

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January 1, 2013

Effect of baseline rheumatoid factor and anticitrullinated peptide antibody serotype on rituximab clinical response: A meta-analysis

Annals of the Rheumatic Diseases, ISSN: 14682060 00034967

John D. Isaacs; Stanley B. Cohen; Paul Emery; Paul P. Tak; Jianmei Wang; Guiyuan Lei; Sarah Williams; Preeti Lal; Simon J. Read

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January 1, 2013

Avoiding pitfalls during technology transfer of cell culture manufacturing processes in the pharmaceutical industry - Mitigating risk and optimizing performance

Pharmaceutical Outsourcing, ISSN: 19453337

Michael Pohlscheidt; Mahalia Corrales; Salim Charanyia; Eric Fallon; Manfred Bruch; Marco Jenzsch; Christian Sieblist

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January 1, 2013

The advantages of frontotemporal degeneration drug development (part 2 of frontotemporal degeneration: The next therapeutic frontier)

Alzheimer's and Dementia, ISSN: 15525279 15525260

Adam L. Boxer; Michael Gold; Edward Huey; William T. Hu; Howard J. Rosen; Joel H. Kramer; Fen-Biao Gao; Edward A. Burton; Tiffany Chow; Aimee Kao; Blair R. Leavitt; Bruce Lamb; Megan Grether; David Knopman; Nigel J. Cairns; Ian R. Mackenzie; Laura Mitic; Erik D. Roberson; Daniel Van Kammen; Marc Cantillon; Kathleen Zahs; George Jackson; Stephen Salloway; John C. Morris; Gary Tong; Howard Feldman; Howard Fillit; Susan Dickinson; Zaven S. Khachaturian; Margaret Sutherland; Susan Abushakra; Joe Lewcock; Robert Farese; Robert O. Kenet; Frank Laferla; Steve Perrin; Steve Whitaker; Lawrence S. Honig; Marsel M. Mesulam; Brad Boeve; Murray Grossman; Bruce L. Miller; Jeffrey L. Cummings

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January 1, 2013

Response

Chest, ISSN: 19313543 00123692

Nareg Roubinian; Paul D. Blanc; Hubert Chen

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January 1, 2013

Redefining approaches to asthma: Developing targeted biologic therapies

Advances in Pharmacology, ISSN: 15578925 10543589

Joseph R. Arron; Heleen Scheerens; Matthews

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January 1, 2013

Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): A randomised, double-blind, controlled phase 4 trial

The Lancet, ISSN: 1474547X 01406736

Cem Gabay; Paul Emery; Ronald Van Vollenhoven; Ara Dikranian; Rieke Alten; Karel Pavelka; Micki Klearman; David Musselman; Sunil Agarwal; Jennifer Green; Arthur Kavanaugh

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January 1, 2013

Polar solvents decrease the viscosity of high concentration IgG1 solutions through hydrophobic solvation and interaction: Formulation and biocompatibility considerations

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Tim J. Kamerzell; Amanda L. Pace; Megan Li; Dimitry Danilenko; Michelle Mcdowell; Yatin Gokarn; Y. John Wang

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January 1, 2013

Use of Animal Models of Human Disease for Nonclinical Safety Assessment of Novel Pharmaceuticals

Toxicologic Pathology, ISSN: 15331601 01926233

Sherry J. Morgan; Chandikumar S. Elangbam; Shawn Berens; Evan B. Janovitz; Allison Vitsky; Tanja S. Zabka; Laura Conour

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January 1, 2013

Ubiquilin4 is an adaptor protein that recruits Ubiquilin1 to the autophagy machinery

EMBO Reports, ISSN: 14693178 1469221X

Dong Yun Lee; David Arnott; Eric J. Brown

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January 1, 2013

The cost burden of multiple sclerosis in the United States: A systematic review of the literature

Journal of Medical Economics, ISSN: 1941837X 13696998

Gabriel Adelman; Stanley G. Rane; Kathleen F. Villa

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January 1, 2013

NMDA receptors in nervous system diseases

Neuropharmacology, ISSN: 18737064 00283908

Qiang Zhou; Morgan Sheng

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January 1, 2013

Sensitivity and specificity of diagnostic accuracy in alzheimer's disease: A synthesis of existing evidence

American Journal of Alzheimer's Disease and other Dementias, ISSN: 19382731 15333175

Joseph E. Gaugler; Robert L. Kane; Joseph A. Johnston; Khaled Sarsour

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January 1, 2013

Label-free high-throughput assays to screen and characterize novel lactate dehydrogenase inhibitors

Analytical Biochemistry, ISSN: 10960309 00032697

Erica Vanderporten; Lauren Frick; Rebecca Turincio; Peter Thana; William LaMarr; Yichin Liu

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January 1, 2013

NMDA receptor subunit diversity: Impact on receptor properties, synaptic plasticity and disease

Nature Reviews Neuroscience, ISSN: 14710048 1471003X

Pierre Paoletti; Camilla Bellone; Qiang Zhou

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January 1, 2013

Asparagine deamidation dependence on buffer type, pH, and temperature

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Amanda L. Pace; Wong; Taylor Zhang; Kao; Y. John Wang

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January 1, 2013

Degradation of a pharmaceutical in HPLC grade methanol containing trace level formaldehyde

Pharmaceutical Development and Technology, ISSN: 10979867 10837450

Qiqing Zhong; Sarah Stowers; Nathaniel Segraves; Kenley K. Ngim; Kelly Zhang; Tracy Bostick; Alan Deese; Nik P. Chetwyn

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January 1, 2013

Nonclinical Development of Multi-targeting Biopharmaceuticals

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,

Prell; Donna W. Lee; Wendy Halpern; Anu V. Connor

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January 1, 2013

Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,

Theresa Reynolds; Christina de Zafra; Amy H. Kim; Thomas R. Gelzleichter

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January 1, 2013

Analysis of cognitive, functional, health service use, and cost trajectories prior to and following memory loss

Journals of Gerontology - Series B Psychological Sciences and Social Sciences, ISSN: 10795014

Joseph E. Gaugler; Martha Hovater; David L. Roth; Joseph A. Johnston; Robert L. Kane; Khaled Sarsour

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January 1, 2013

Multimodal microvascular imaging reveals that selective inhibition of class I PI3K is sufficient to induce an antivascular response

Neoplasia (United States), ISSN: 14765586 15228002

Deepak Sampath; Jason Oeh; Shelby K. Wyatt; Tim C. Cao; Koeppen; Jeffrey Eastham-Anderson; Liliane Robillard; Calvin Ho; Ross; Guanglei Zhuang; Hani Bou-Reslan; Philip Vitorino; Kai H. Barck; Sharon E. Ungersma; Jean-Michel Vernes; Maresa Caunt; Nicholas Van Bruggen; Weilan Ye; Ulka Vijapurkar; Yu-Ju Gloria Meng; Napoleone Ferrara; Lori S. Friedman; Richard A. D. Carano

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January 1, 2013

On the accuracy of a one-compartment approach for determination of drug terminal half-life

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Leonid M. Berezhkovskiy

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January 1, 2013

The authors reply

New England Journal of Medicine, ISSN: 15334406 00284793

Marcus Maurer; Karin Rosén; Hsin-Ju Hsieh

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January 1, 2013

Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy

Journal of Allergy and Clinical Immunology, ISSN: 10976825 00916749

Allen P. Kaplan; Dennis Ledford; Ashby; Janice Canvin; James L. Zazzali; Edward Conner; Joachim Veith; Nikhil Kamath; Petra Staubach; Thilo Jakob; Robert G. Stirling; Piotr Kuna; William Berger; Marcus Maurer; Karin Rosén

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January 1, 2013

Early Characterization of Biosimilar Therapeutics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics,

Thomas R. Gelzleichter

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January 1, 2013

Large-scale integrative network-based analysis identifies common pathways disrupted by copy number alterations across cancers

BMC Genomics, ISSN: 14712164

Tae Hyun Hwang; Gowtham Atluri; Rui Kuang; Vipin Kumar; Timothy Starr; Kevin A.T. Silverstein; Matthias Peter; Zemin Zhang; Jinfeng Liu

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January 1, 2013

Antibody therapeutics in cancer

Science, ISSN: 10959203 00368075

Mark X. Sliwkowski; Ira Mellman

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January 1, 2013

Effect of ionic strength and pH on the physical and chemical stability of a monoclonal antibody antigen-binding fragment

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Tingting Wang; Ozan S. Kumru; Li Yi; Y. John Wang; Jennifer Zhang; Jae Hyun Kim; Sangeeta B. Joshi; C. Russell Middaugh; David B. Volkin

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January 1, 2013

Molecular Heterogeneity, Biomarker Discovery, and Targeted Therapy in Asthma

Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Health Care,

Joseph R. Arron; Harris

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January 1, 2013

Comparison of in vitro-in vivo extrapolation of biliary clearance using an empirical scaling factor versus transport-based scaling factors in sandwich-cultured rat hepatocytes

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Peng Zou; Xingrong Liu; Susan C. Wong; Meihua Rose Feng; Bianca M. Liederer

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January 1, 2013

High eosinophil count: A potential biomarker for assessing successful omalizumab treatment effects

Journal of Allergy and Clinical Immunology, ISSN: 10976825 00916749

William W. Busse; Sheldon Spector; Karin Rosén; Yan Wang; Oral Alpan

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January 1, 2013

Knobs-into-holes antibody production in mammalian cell lines reveals that asymmetric afucosylation is sufficient for full antibody-dependent cellular cytotoxicity

mAbs, ISSN: 19420870 19420862

Whitney Shatz; Shan Chung; Bing Li; Brett Marshall; Max L. Tejada; Wilson Phung; Wendy N. Sandoval; Robert F. Kelley; Justin M. Scheer

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January 1, 2013

Bispecific antibodies with natural architecture produced by co-culture of bacteria expressing two distinct half-antibodies

Nature Biotechnology, ISSN: 15461696 10870156

Christoph Spiess; Mark Merchant; Arthur Huang; Zhong Zheng; Nai-Ying Yang; Jing Peng; Diego Ellerman; Whitney Shatz; Dorothea Reilly; Yansura; Justin M. Scheer

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January 1, 2013

High shear rheology and anisotropy in concentrated solutions of monoclonal antibodies

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Isidro E. Zarraga; Rosalynn Taing; Jonathan Zarzar; Jacob Luoma; Jenny Hsiung; Ankit Patel; Fred Lim

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January 1, 2013

Trehalose limits BSA aggregation in spray-dried formulations at high temperatures: Implications in preparing polymer implants for long-term protein delivery

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Karthikan Rajagopal; Joseph Wood; Benjamin Tran; Thomas W. Patapoff; Thierry Nivaggioli

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January 1, 2013

Efficacy of remission-induction regimens for ANCA-associated vasculitis

New England Journal of Medicine, ISSN: 15334406 00284793

Specks; Merkel; Seo; Spiera; Langford; Hoffman; Cees Kallenberg; St.clair; Barri J. Fessler; Linna Ding; Viviano; Tchao; Deborah J. Phippard; Adam Asare; Noha Lim; Iklé; Brett Jepson; Paul Brunetta; Allen; Fervenza; Duvuru Geetha; Keogh; Kissin; Monach; Peikert; Stegeman; Steven R. Ytterberg; Mark Mueller; Lourdes P. Sejismundo; Kathleen Mieras; John H. Stone

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January 1, 2013

Mechanism of MEK inhibition determines efficacy in mutant KRAS- versus BRAF-driven cancers

Nature, ISSN: 14764687 00280836

Georgia Hatzivassiliou; Jacob R. Haling; Huifen Chen; Kyung Song; Steve Price; Robert Heald; Joanne F. M. Hewitt; Mark Zak; Ariana Peck; Christine Orr; Mark Merchant; Klaus P. Hoeflich; Jocelyn Chan; Shiuh-Ming Luoh; Daniel J Anderson; Mary J. C. Ludlam; Wiesmann; Ultsch; Lori S. Friedman; Shiva Malek; Marcia Belvin

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January 1, 2013

NMR study to identify a ligand-binding pocket in ras

Enzymes, ISSN: 18746047

Till Maurer; Weiru Wang

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January 1, 2013

Lead identification of novel and selective TYK2 inhibitors

European Journal of Medicinal Chemistry, ISSN: 17683254 02235234

Jun Liang; Vickie Tsui; Anne Van Abbema; Liang Bao; Kathy Barrett; Beresini; Leonid M. Berezhkovskiy; Wade S. Blair; Christine Chang; James Driscoll; Eigenbrot; Nico Ghilardi; Paul Gibbons; Jason S Halladay; Adam R. Johnson; Pawan Bir Kohli; Yingjie Lai; Marya Liimatta; Priscilla Mantik; Kapil Menghrajani; Jeremy Murray; Amy Sambrone; Yisong Xiao; Steven Shia; Young G. Shin; Jan Smith; Sue J. Sohn; Mark S. Stanley; Ultsch; Birong Zhang; Lawren C. Wu; Steven Magnuson

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January 1, 2013

A phase 2, double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the efficacy, safety, and tolerability of naloxegol in patients with opioid-induced constipation

Pain, ISSN: 18726623 03043959

Lynn Webster; Sunita Dhar; Michael Eldon; Lorianne Masuoka; Jaakko Lappalainen; Mark Sostek

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January 1, 2013

Increased glucocerebrosidase (GBA) 2 activity in GBA1 deficient mice brains and in Gaucher leucocytes

Journal of Inherited Metabolic Disease, ISSN: 15732665 01418955

Derek G. Burke; Ahad A. Rahim; Simon N. Waddington; Stefan Karlsson; Ida Enquist; Kailash Bhatia; Atul Mehta; Ashok Vellodi; Simon Heales

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January 1, 2013

Dose-ranging study of lebrikizumab in asthmatic patients not receiving inhaled steroids

Journal of Allergy and Clinical Immunology, ISSN: 10976825 00916749

Michael Noonan; Phillip Korenblat; Mosesova; Heleen Scheerens; Joseph R. Arron; Zheng; Wendy Putnam; Merdad V. Parsey; Sean P. Bohen; Matthews

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January 1, 2013

Critical review of preclinical approaches to investigate cytochrome P450-mediated therapeutic protein drug-drug interactions and recommendations for best practices: A white paper

Drug Metabolism and Disposition, ISSN: 1521009X 00909556

Raymond Evers; Shannon Dallas; Leslie Dickmann; Odette A. Fahmi; Jane R. Kenny; Eugenia Kraynov; Theresa Nguyen; Aarti H. Patel; J. Greg Slatter; Lei Zhang

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January 1, 2013

Bevacizumab plus chemotherapy continued beyond first progression in patients withmetastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings

Annals of Oncology, ISSN: 15698041 09237534

Stefan Kubicka; Greil; André; Bennouna; Sastre; Eric Van Cutsem; Von Moos; Österlund; Reyes-Rivera; Thomas Müller; Makrutzki; Arnold; Andel; Balcke; Benedicic; Eisterer; Fridrik; Jagdt; Keil; Kretschmer; Krippl; Oexle; Pecherstorfer; Samonigg; Schmid; Thaler; Tinchon; Weiss; Arts; De Man; Demolin; Janssens; Polus; Benczikova; Melichar; Prausova; Vitek; Andersen; Jensen; Keldsen; Østerlind; Vistisen; Elme; Magi; Ojamaa; Ristamäki; Salminen; Ben Abdelghani; Bouche; Borg; Bouhier-Leporrier; Breysacher; Chone; Clavero Fabri; Deplanque; Desseigne; Dourthe; Ezenfis; Faroux; François; Garnier; Gaspard; Hebbar; Illory; Kaminsky; Lecomte; Legoux; Levache; Lobry; Lotz; Mabro; Manet-Lacombe; Manfredi; Matysiak Budnik; Miglianico; Mineur; Moullet; Naman; Nouyrigat; Oziel-Taieb; Perrier; Pezet; Philip; Pottier; Porneuf; Ramdani; Re; Rinaldi; Spaeth; Taieb; Terrebonne; Texereau; Thirot Bidault; Tournigand; Tubiana-Mathieu; Vantelon; Viret; Ychou; Bangerter; Bertram; Bohnsteen; Brinkmann; Caca; Constantin; Cordes; Dietrich; Eggert; Engel; Fahlke; Fensterer; Florschütz; Folprecht; Forstbauer; Freier; Freund; Frickhofen; Gäbele; Geißler; Gieseler; Göhler; Graeven; Groschek; Grundeis; Hacker; Hagen; Hebart; Hegewisch-Becker; Heike; Herrmann; Hildebrandt; Höffkes; Hübner; Hübner; Kettner; Kneba; Kohnke; Kojouharoff; König; Kretzschmar; Kröning; Kürner; Lammert; Lerchenmüller; Lück; Meiler; Mergenthaler; Müller; Müller-Naendrup; Nusch; Papke; Porschen; Rädle; Reddemann; Ridwelski; Riera-Knorrenschild; Rudi; Schmalenberger; Schimanski; Schlegel; Schlichting; Schmidt; Schmiegel; Schmitz; Schulze-Bergkamen; Schwaner; Schwarzer; Schwerdtfeger; Selbach; Sieber; Jürgen Siebler; Staib; Stauch; Steffens; Stübs; Tischendorf; Trarbach; Tummes; Valdix; Vogel; Von Wichert; Walther; Welslau; Wilhelm; Wobster; Wolf; Zeigenhagen; Zomorodbaksch; Batman; Bloemendal; Kehrer; Guren; Indrebø; Kersten; Soerbye; Fragoso; Fragoso; Mellidez; Sa; Aljobran; Darwish; Alonso-Orduna; Aparicio; Aranda; Bosch; Galan-Brotons; Busquier Hernandez; Camara; Campos Cervera; Carlos Garcia Giron; Del Prado; Donnay; Escudero; Falco; Gallego Plazas; Garcia Alfonso; Gonzalez Flores; Gravalos; Guardeno; Juárez; Lopez Ladron; Losa Gaspa; MaVicent Vergé; Marcuello Gaspar; Massuti Sureda; Molina; Montero; Muñoa; Naranjo; Oruezabal Moreno; Pachón Olmos; Pericay; Reina Zoilo; Rivera; Ruiz Casado; Safont; Salud Salvia; Tobena; Toral; Valenti; Valladares Ayerbes; Vieitez; Vera; Vieitez; Berglund; Fernebro; Hess-Umbricht; Miklos Pless; Popescu; Winterhalder

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January 1, 2013

Operationalization of Global Alzheimer's Disease Trials

Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization,

Lynne Hughes; Spencer Guthrie

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January 1, 2013

Effects of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys

mAbs, ISSN: 19420870 19420862

Maya Leabman; Meng; Robert F. Kelley; Laura DeForge; Kyra J. Cowan; Suhasini Iyer

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January 1, 2013

Systemic in vitro and in vivo evaluation for determining the feasibility of making an amorphous solid dispersion of a B-Raf (rapidly accelerated fibrosarcoma) inhibitor

International Journal of Pharmaceutics, ISSN: 18733476 03785173

Yong Cui; Po-Chang Chiang; Edna F. Choo; Jason Boggs; Joachim Rudolph; Jonas Grina; Steve Wenglowsky; Yingqing Ran

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