Genentech: Publications

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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January 1, 2013

Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naïve patients with hepatitis c virus genotype 1 infection

Gastroenterology, ISSN: 15280012 00165085

Marcellin; Curtis Cooper; Luis Balart; Dominique Larrey; Terry Box; Eric Yoshida; Eric Lawitz; Peter Buggisch; Peter Ferenci; Martin D. Weltman; Emily Labriola-Tompkins; Sophie Le Pogam; Nájera; Denise Thomas; Gregory J. Hooper; Nancy Shulman; Ying Zhang; Mercidita T. Navarro; Chin Yin Lim; Michael Brunda; Terrault; Ellen S. Yetzer

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January 1, 2013

Independent radiologic reviewof the Gynecologic Oncology Group Study 0218, a phase III trial of bevacizumab in the primary treatment of advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer

Gynecologic Oncology, ISSN: 10956859 00908258

Robert. A. Burger; Mark F. Brady; Joon Rhee; Mika A. Sovak; George Kong; Hoa P. Nguyen; Michael A. Bookman

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January 1, 2013

An algorithm for evaluating potential tissue drug distribution in toxicology studies from readily available pharmacokinetic parameters

Journal of Pharmaceutical Sciences, ISSN: 15206017 00223549

Patrick Poulin; Donna M. Dambach; Dylan H. Hartley; Kevin A. Ford; Frank-Peter Theil; Eric Harstad; Jason S Halladay; Edna F. Choo; Jason Boggs; Bianca M. Liederer; Brian J. Dean; Dolores Diaz

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January 1, 2013

Probability of treatment following acute decline in lung function in children with cystic fibrosis is related to baseline pulmonary function

Journal of Pediatrics, ISSN: 10976833 00223476

Morgan; Wagener; Ashley Yegin; David J. Pasta; Stefanie J. Millar; Michael W. Konstan

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January 1, 2013

Supplementation of nicotinic acid with NAMPT inhibitors results in loss of in vivo efficacy in NAPRT1-deficient tumor models

Neoplasia (United States), ISSN: 14765586 15228002

Thomas O'Brien; Jason Oeh; Yang Xiao; Xiaorong Liang; Alexander N. Vanderbilt; Ann R. Qin; Lulu Yang; Leslie Lee; Justin Ly; Ely Cosino; Jennifer A. Lacap; Annie Ogasawara; Simon P. Williams; Michelle Nannini; Bianca M. Liederer; Peter K Jackson; Peter Dragovich; Deepak Sampath

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January 1, 2013

Assessment of computational methods for predicting the effects of missense mutations in human cancers.

BMC Genomics, ISSN: 14712164

Florian Gnad; Albion Baucom; Kiran Mukhyala; Gerard Manning; Zemin Zhang

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January 1, 2013

Health-related quality of life in patients with advanced nonsquamous non-small-cell lung cancer receiving bevacizumab or bevacizumab-plus-pemetrexed maintenance therapy in AVAPERL (MO22089)

Journal of Thoracic Oncology, ISSN: 15561380 15560864

Achim Rittmeyer; Vera Gorbunova; Anders Vikström; Arnaud Scherpereel; Joo-Hang Kim; Myung-Ju Ahn; Antonio Chella; Christos Chouaid; Alicyn K. Campbell; Fabrice Barlesi

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January 1, 2013

CDKN2A/p16 inactivation mechanisms and their relationship to smoke exposure and molecular features in non-small-cell lung cancer

Journal of Thoracic Oncology, ISSN: 15561380 15560864

Kit W. Tam; Wei Zhang; Junichi Soh; Victor Stastny; Min Chen; Han Sun; Kelsie Thu; Jonathan J. Rios; Chenchen Yang; Crystal N. Marconett; Suhaida. A. Selamat; Ite A. Laird-Offringa; Ayumu Taguchi; Samir Hanash; David S. Shames; Xiaotu Ma; Michael Q. Zhang; Wan L. Lam; Adi Gazdar

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January 1, 2013

The effects of membrane filters used in biopharmaceutical processes on the concentration and composition of polysorbate 20

Biotechnology Progress, ISSN: 15206033 87567938

Ming Lei; Daniel Hewitt; Christopher Cornell; Ken Skidmore; Kao; Jimmy Sugahara; Diane Beane; Junyan A. Ji

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January 1, 2013

Mapping in vivo tumor oxygenation within viable tumor by 19F-MRI and multispectral analysis

Neoplasia (United States), ISSN: 14765586 15228002

Yunzhou Shi; Jason Oeh; Jeffrey Eastham-Anderson; Sharon Fong Yee; David Finkle; Franklin V. Peale Jr.; Ross; Maj Hedehus; Nicholas Van Bruggen; Rayna Venook; Ross; Deepak Sampath; Richard A. D. Carano

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January 1, 2013

Scale-down studies for assessing the impact of different stress parameters on growth and product quality during animal cell culture

Chemical Engineering Research and Design, ISSN: 02638762

Alvin W. Nienow; William H. Scott; Christopher J. Hewitt; Colin R. Thomas; Gareth Lewis; Ashraf Amanullah; Robert Kiss; Steven Meier

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January 1, 2013

First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: Pooled and subgroup analyses of data from 2447 patients

Annals of Oncology, ISSN: 15698041 09237534

David W. Miles; Diéras; Javier Cortés; Duenne; Joo-Hee Yi; O'Shaughnessy

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January 1, 2013