Barbara Mounho : rechercher sur Z-Library

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1

The Role of the Study Director in Nonclinical Studies || Regulatory Inspections

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 248 KB

english, 2014

2

Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate?

Janet Clarke, Christopher Hurst, Pauline Martin, John Vahle, Rafael Ponce, Barbara Mounho, Shawn Heidel, Laura Andrews, Theresa Reynolds, Joy Cavagnaro

Journal:

Regulatory Toxicology and Pharmacology

Année:

2008

Langue:

english

Fichier:

PDF, 271 KB

english, 2008

3

The Role of the Study Director in Nonclinical Studies || International Guidelines and Regulations of Nonclinical Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 478 KB

english, 2014

4

The Role of the Study Director in Nonclinical Studies || Analytical Chemistry and Toxicology Formulations

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 655 KB

english, 2014

5

The Role of the Study Director in Nonclinical Studies || Project Management and the Role of a Study Director

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 368 KB

english, 2014

6

The Role of the Study Director in Nonclinical Studies || Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 454 KB

english, 2014

7

The Role of the Study Director in Nonclinical Studies || The Planning, Conduct, and Interpretation of Safety Pharmacology Studies: The Role of the Study Director in Safety Pharmacology Investigations

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 561 KB

english, 2014

8

The Role of the Study Director in Nonclinical Studies || Introduction to the Study Director

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 151 KB

english, 2014

9

The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment

Janice A. Lansita,Barbara Mounho-Zamora

Journal:

Current Pain and Headache Reports

Année:

2015

Langue:

english

Fichier:

PDF, 831 KB

english, 2015

10

An Introduction to the Regulatory and Nonclinical Aspects of the Nonclinical Development of Antibody Drug Conjugates

Lansita, Janice A., Burke, John M., Apgar, Joshua F., Mounho-Zamora, Barbara

Journal:

Pharmaceutical Research

Année:

2015

Langue:

english

Fichier:

PDF, 416 KB

english, 2015

11

The Role of the Study Director in Nonclinical Studies ||

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 16.26 MB

english, 2014

12

Pharmacokinetics and Safety of a Fully Human Hepatocyte Growth Factor Antibody, AMG 102, in Cynomolgus Monkeys

Tarundeep Kakkar, Mark Ma, Yao Zhuang, Aaron Patton, Zheng Hu, Barbara Mounho

Journal:

Pharmaceutical Research

Année:

2007

Langue:

english

Fichier:

PDF, 758 KB

english, 2007

13

10.1038/86397

Lawrence, David, Shahrokh, Zahra, Marsters, Scot, Achilles, Kirsten, Shih, Danny, Mounho, Barbara, Hillan, Kenneth, Totpal, Klara, DeForge, Laura, Schow, Peter, Hooley, Jeffrey, Sherwood, Steve, Pai,

Journal:

Nature Medicine

Année:

2001

Langue:

english

Fichier:

PDF, 1.30 MB

english, 2001

14

Depletion of Glutathione by Benzo(a)pyrene Metabolites, Ionomycin, Thapsigargin, and Phorbol Myristate in Human Peripheral Blood Mononuclear Cells

David L. Romero, Barbara J. Mounho, Fredine T. Lauer, Jerry L. Born, Scott W. Burchiel

Journal:

Toxicology and Applied Pharmacology

Année:

1997

Langue:

english

Fichier:

PDF, 129 KB

english, 1997

15

Characterization of Intracellular Calcium Responses Produced by Polycyclic Aromatic Hydrocarbons in Surface Marker-Defined Human Peripheral Blood Mononuclear Cells

Barbara J. Mounho, Donna R. Davila, Scott W. Burchiel

Journal:

Toxicology and Applied Pharmacology

Année:

1997

Langue:

english

Fichier:

PDF, 157 KB

english, 1997

16

Alterations in Human B Cell Calcium Homeostasis by Polycyclic Aromatic Hydrocarbons: Possible Associations with Cytochrome P450 Metabolism and Increased Protein Tyrosine Phosphorylation

Barbara J. Mounho, Scott W. Burchiel

Journal:

Toxicology and Applied Pharmacology

Année:

1998

Langue:

english

Fichier:

PDF, 352 KB

english, 1998

17

The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro

Barbara J. Mounho, Brian D. Thrall

Journal:

Toxicology and Applied Pharmacology

Année:

1999

Langue:

english

Fichier:

PDF, 324 KB

english, 1999

18

Survey results on the use of the tissue cross-reactivity immunohistochemistry assay

Jeanine L. Bussiere, Michael W. Leach, Karen D. Price, Barbara J. Mounho, Ruth Lightfoot-Dunn

Journal:

Regulatory Toxicology and Pharmacology

Année:

2011

Langue:

english

Fichier:

PDF, 438 KB

english, 2011

19

Uses and Future Applications of Flow Cytometry in Immunotoxicity Testing

Scott W. Burchiel, Fredine T. Lauer, Debbie Gurulé, Barbara J. Mounho, Virginia M. Salas

Journal:

Année:

1999

Langue:

english

Fichier:

PDF, 195 KB

english, 1999

20

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics || Regulatory Standards for the Approval of Biosimilar Products

Mounho-Zamora, Barbara

Année:

2013

Langue:

english

Fichier:

PDF, 486 KB

english, 2013

21

The Role of the Study Director in Nonclinical Studies || Managing Multi-site Studies: Roles of the Principal Investigator and the Study Director

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 305 KB

english, 2014

22

The Role of the Study Director in Nonclinical Studies || In Vitro Toxicology Models

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 1.32 MB

english, 2014

23

The Role of the Study Director in Nonclinical Studies || Toxicokinetics and Bioanalysis

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 622 KB

english, 2014

24

The Role of the Study Director in Nonclinical Studies || Facilities, Operations, Laboratory Animal Care, and Veterinary Services

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 741 KB

english, 2014

25

The Role of the Study Director in Nonclinical Studies || Histopathology in Toxicity Studies for Study Directors

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 4.16 MB

english, 2014

26

The Role of the Study Director in Nonclinical Studies || Prestudy Preparation, the Protocol, Data Interpretation, and Reporting

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 590 KB

english, 2014

27

The Role of the Study Director in Nonclinical Studies || Clinical Pathology

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 477 KB

english, 2014

28

The Role of the Study Director in Nonclinical Studies || Vaccines: Preventive and Therapeutic Product Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 622 KB

english, 2014

29

The Role of the Study Director in Nonclinical Studies || Study Conduct

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 296 KB

english, 2014

30

The Role of the Study Director in Nonclinical Studies || Effective Incorporation and Utilization of Biomarkers in Nonclinical Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 307 KB

english, 2014

31

The Role of the Study Director in Nonclinical Studies || Medical Devices

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 554 KB

english, 2014

32

The Role of the Study Director in Nonclinical Studies || Immunotoxicology in Nonclinical Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 352 KB

english, 2014

33

The Role of the Study Director in Nonclinical Studies || Genetic Toxicology Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 574 KB

english, 2014

34

The Role of the Study Director in Nonclinical Studies || Pathology: Necropsy and Gross Pathology

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 386 KB

english, 2014

35

The Role of the Study Director in Nonclinical Studies || Carcinogenicity Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 445 KB

english, 2014

36

The Role of the Study Director in Nonclinical Studies || Contemporary Practices in Core Developmental, Reproductive, and Juvenile Toxicity Assessments

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 1.05 MB

english, 2014

37

The Role of the Study Director in Nonclinical Studies || Statistical Design and Analysis of Studies

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 1.62 MB

english, 2014

38

The Role of the Study Director in Nonclinical Studies || Lessons from the Front Lines

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 304 KB

english, 2014

39

The Role of the Study Director in Nonclinical Studies || Toxicology Studies Conducted for Pesticides and Commodity Chemicals

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 561 KB

english, 2014

40

The Role of the Study Director in Nonclinical Studies || Nonclinical Safety Assessment of Biotechnology-Derived Products: Considerations and Challenges

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 556 KB

english, 2014

41

The Role of the Study Director in Nonclinical Studies || Gene and Cell Therapy Products

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 282 KB

english, 2014

42

The Role of the Study Director in Nonclinical Studies || Index

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 831 KB

english, 2014

43

The Role of the Study Director in Nonclinical Studies || Front Matter

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 211 KB

english, 2014

44

The Role of the Study Director in Nonclinical Studies || Color Plates

Brock, William J., Mounho, Barbara, Fu, Lijie

Année:

2014

Langue:

english

Fichier:

PDF, 5.62 MB

english, 2014

45

Concomitant Administration of Bevacizumab, Irinotecan, 5-Fluorouracil, and Leucovorin: Nonclinical Safety and Pharmacokinetics

Gaudreault, Jacques, Shiu, Vanessa, Bricarello, Ann, Christian, Brian, Zuch, Christina, Mounho, Barbara

Journal:

International Journal of Toxicology

Année:

2005

Langue:

english

Fichier:

PDF, 100 KB

english, 2005

46

Biosimilars 2.0

Miletich, Joseph, Eich, Geoffrey, Grampp, Gustavo, Mounho, Barbara

Journal:

Année:

2011

Langue:

english

Fichier:

PDF, 1.52 MB

english, 2011

47

Antitherapeutic antibody-mediated hepatotoxicity of recombinant human Apo2L/TRAIL in the cynomolgus monkey

Zuch de Zafra, Christina L, Ashkenazi, Avi, Darbonne, Walter C, Cheu, Melissa, Totpal, Klara, Ortega, Shirley, Flores, Heather, Walker, Mark D, Kabakoff, Bruce, Lum, Bert L, Mounho-Zamora, Barbara J,

Journal:

Cell Death and Disease

Année:

2016

Langue:

english

Fichier:

PDF, 1.88 MB

english, 2016