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Leach, Michael W.
1888  Ergebnisse:
Personensuche X
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1

Translation of nonclinical to clinical safety findings for ..:

Leach, Michael W. ; Rana, Payal ; Hu, Wenyue...
Toxicology and Applied Pharmacology.  484 (2024)  - p. 116854 , 2024
Link: https://doi.org/10.1016/..
 
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2

The use of recovery animals in nonclinical safety assessmen..:

Prior, Helen ; Andrews, Laura ; Cauvin, Annick...
Regulatory Toxicology and Pharmacology.  138 (2023)  - p. 105339 , 2023
Link: https://doi.org/10.1016/..
 
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3

Re-evaluating the need for chronic toxicity studies with th..:

Chien, Hsiao-Tzu ; Prior, Helen ; Andrews, Laura...
Regulatory Toxicology and Pharmacology.  138 (2023)  - p. 105329 , 2023
Link: https://doi.org/10.1016/..
 
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4

Classic and evolving approaches to evaluating cross reactiv..:

MacLachlan, Timothy K. ; Price, Shari ; Cavagnaro, Joy...
Regulatory Toxicology and Pharmacology.  121 (2021)  - p. 104872 , 2021
Link: https://doi.org/10.1016/..
 
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5

Strategies and Recommendations for Using a Data‐Driven and ..:

Leach, Michael W. ; Clarke, David O. ; Dudal, Sherri...
Clinical Pharmacology & Therapeutics.  109 (2020)  6 - p. 1395-1416 , 2020
Link: https://doi.org/10.1002/..
 
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6

Comparative nonclinical assessments of the biosimilar PF-06..:

Derzi, Mazin ; Shoieb, Ahmed M. ; Ripp, Sharon L....
Regulatory Toxicology and Pharmacology.  112 (2020)  - p. 104587 , 2020
Link: https://doi.org/10.1016/..
 
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7

Nonclinical assessments of the potential biosimilar PF-0643..:

Peraza, Marjorie A. ; Rule, Karen E. ; Shiue, Michael H.I....
Regulatory Toxicology and Pharmacology.  95 (2018)  - p. 236-243 , 2018
Link: https://doi.org/10.1016/..
 
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8

Nonclinical Evaluation of PF-06438179: A Potential Biosimil..:

Derzi, Mazin ; Johnson, Theodore R. ; Shoieb, Ahmed M....
Advances in Therapy.  33 (2016)  11 - p. 1964-1982 , 2016
Link: https://doi.org/10.1007/..
 
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9

Waiving in vivo studies for monoclonal antibody biosimilar ..:

Chapman, Kathryn ; Adjei, Akosua ; Baldrick, Paul...
mAbs.  8 (2016)  3 - p. 427-435 , 2016
Link: https://doi.org/10.1080/..
 
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10

Nonproliferative and Proliferative Lesions ofthe Gastrointe..:

Nolte, Thomas ; Brander-Weber, Patricia ; Dangler, Charles...
Journal of Toxicologic Pathology.  29 (2016)  1_Suppl - p. 1S-125S , 2016
Link: https://doi.org/10.1293/..
 
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11

A Synopsis of the "Influence of Epigenetics, Genetics, and ..:

Harrill, Alison H. ; Moggs, Jonathan G. ; Adkins, Karissa K....
Toxicologic Pathology.  45 (2016)  1 - p. 114-118 , 2016
Link: https://doi.org/10.1177/..
 
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12

Contributors:

, In: The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment,
Barrow, Paul ; Bayne, Kathryn ; Bluemel, Joerg... - p. xiii-xv , 2015
Link: https://doi.org/10.1016/..
 
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13

Scientific and Regulatory Policy Committee Points-to-consid..:

Frazier, Kendall S. ; Engelhardt, Jeffery A. ; Fant, Pierluigi...
Toxicologic Pathology.  43 (2015)  7 - p. 915-934 , 2015
Link: https://doi.org/10.1177/..
 
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14

Nonclinical Toxicology Testing Strategies and Applicable In..:

, In: The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment,
Marque, Todd ; Leach, Michael W. - p. 315-336 , 2015
Link: https://doi.org/10.1016/..
 
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15

Scientific and Regulatory Policy Committee Points-to-consid..:

Engelhardt, Jeffery A. ; Fant, Pierluigi ; Guionaud, Silvia...
Toxicologic Pathology.  43 (2015)  7 - p. 935-944 , 2015
Link: https://doi.org/10.1177/..
 
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