Use of recovery animals for human safety assessment across the pharmaceutical development package

2018 ◽  
Vol 295 ◽  
pp. S223-S224
Author(s):  
F. Sewell ◽  
N. Gellatly ◽  
H. Prior
Keyword(s):  
Safety Assessment ◽  
Pharmaceutical Development ◽  
Human Safety

Phase I Human Safety Assessment of Intrathecal Neostigmine Containing Methyl- and Propylparabens

1997 ◽  
Vol 85 (4) ◽  
pp. 842-846 ◽  
Author(s):  
James C. Eisenach ◽  
David D. Hood ◽  
Regina Curry
Keyword(s):  
Phase I ◽  
Safety Assessment ◽  
Human Safety

Phase I Human Safety Assessment of Intrathecal Neostigmine Containing Methyl- and Propylparabens

1997 ◽  
Vol 85 (4) ◽  
pp. 842-846 ◽  
Author(s):  
James C. Eisenach ◽  
David D. Hood ◽  
Regina Curry
Keyword(s):  
Phase I ◽  
Safety Assessment ◽  
Human Safety

Agricultural Chemical Safety Assessment: A Multisector Approach to the Modernization of Human Safety Requirements

2006 ◽  
Vol 36 (1) ◽  
pp. 1-7 ◽  
Author(s):  
Neil G. Carmichael ◽  
Hugh A. Barton ◽  
Alan R. Boobis ◽  
Ralph L. Cooper ◽  
Vicki L. Dellarco ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Chemical Safety ◽  
Safety Requirements ◽  
Human Safety ◽  
Agricultural Chemical

Revisiting the value of mouse carcinogenicity bioassays for human safety assessment

2012 ◽  
Vol 211 ◽  
pp. S176 ◽  
Author(s):  
Richard Billington ◽  
Tina Mehta ◽  
Richard Lewis ◽  
Bennard van Raavenzway ◽  
Christian Strupp ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Human Safety

A procedure for human safety assessment during hydropeaking events

2019 ◽  
Vol 661 ◽  
pp. 294-305 ◽  
Author(s):  
Giuseppe Roberto Pisaturo ◽  
Maurizio Righetti ◽  
Claudio Castellana ◽  
Michele Larcher ◽  
Andrea Menapace ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Human Safety

Benzoyl Peroxide: An Integrated Human Safety Assessment for Carcinogenicity

1995 ◽  
Vol 21 (1) ◽  
pp. 87-107 ◽  
Author(s):  
A.L. Kraus ◽  
I.C. Munro ◽  
J.C. Orr ◽  
R.L. Binder ◽  
R.A. Leboeuf ◽  
...  
Keyword(s):  
Benzoyl Peroxide ◽  
Safety Assessment ◽  
Human Safety

scholarly journals Immunophenotyping: Application to Safety Assessment

2017 ◽  
Vol 45 (7) ◽  
pp. 1004-1011 ◽  
Author(s):  
Xiaoting Wang ◽  
Hervé Lebrec
Keyword(s):  
Continuing Education ◽  
Study Design ◽  
Safety Assessment ◽  
Lymphocyte Subsets ◽  
Annual Symposium ◽  
Pharmaceutical Development ◽  
Design Considerations ◽  
Key Points ◽  
Clusters Of Differentiation

A continuing education course entitled “What You Always Wanted to Know About Immunotoxicology in Pharmaceutical Development…But Were Afraid to Ask” was offered at the Society of Toxicologic Pathology (STP) 36th annual symposium in Montreal. This article summarizes some key points made during the presentation dedicated to immunophenotyping. It describes how clusters of differentiation (CDs) are well-defined antigens used to characterize cell subsets, and how lymphocyte subsets in humans and different rodent and nonrodent species can be defined by detection of various combinations of CDs. It provides an overview of immunophenotyping study design considerations and applications to safety assessment.

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