Factors determining the optimal body site and method for obtaining punch biopsies of human skin as a tissue in which to assess pharmacodynamic and pharmacokinetic endpoints in drug development studies

2005 ◽  
Vol 57 (1) ◽  
pp. 52-58 ◽  
Author(s):  
D. R. Camidge ◽  
M. J. Davies ◽  
P. J. Laud ◽  
A. L. Marshall ◽  
M. Cockerill ◽  
...  
Keyword(s):  
Drug Development ◽  
Human Skin ◽  
Development Studies ◽  
Body Site

scholarly journals Qualification of translational safety biomarkers

2021 ◽  
pp. 153537022110021
Author(s):  
John-Michael Sauer ◽  
Amy C Porter
Keyword(s):  
Skeletal Muscle ◽  
Drug Development ◽  
Vascular Injury ◽  
Validation Studies ◽  
Safety Assessment ◽  
Regulatory Agencies ◽  
Development Studies ◽  
Clinical Validation ◽  
Development Tools ◽  
Important Drug

Safety biomarkers are important drug development tools, both preclinically and clinically. It is a straightforward process to correlate the performance of nonclinical safety biomarkers with histopathology, and ideally, the biomarker is useful in all species commonly used in safety assessment. In clinical validation studies, where histopathology is not feasible, safety biomarkers are compared to the response of standard biomarkers and/or to clinical adjudication. Worldwide, regulatory agencies have put in place processes to qualify biomarkers to provide confidence in the manner of use and interpretation of biomarker data in drug development studies. This paper describes currently qualified safety biomarkers which can be utilized to monitor for nephrotoxicity and cardiotoxicity and ongoing projects to qualify safety biomarkers for liver, skeletal muscle, and vascular injury. In many cases, the development and use of these critical drug development tools is dependent upon partnerships and the precompetitive sharing of data to support qualification efforts.

scholarly journals Plucked human hair as a tissue in which to assess pharmacodynamic end points during drug development studies

2005 ◽  
Vol 92 (10) ◽  
pp. 1837-1841 ◽  
Author(s):  
D R Camidge ◽  
K R Randall ◽  
J R Foster ◽  
C J Sadler ◽  
J A Wright ◽  
...  
Keyword(s):  
Drug Development ◽  
Human Hair ◽  
Development Studies ◽  
End Points

scholarly journals A systematic literature review of the human skin microbiome as biomarker for dermatological drug development

2018 ◽  
Vol 84 (10) ◽  
pp. 2178-2193 ◽  
Author(s):  
T. Niemeyer - van der Kolk ◽  
H. E. C. van der Wall ◽  
C. Balmforth ◽  
M. B. A. Van Doorn ◽  
R. Rissmann
Keyword(s):  
Literature Review ◽  
Drug Development ◽  
Human Skin ◽  
Systematic Literature Review ◽  
Skin Microbiome

Are neuronal nicotinic receptors a target for antiepileptic drug development? Studies in different seizure models in mice and rats

2003 ◽  
Vol 466 (1-2) ◽  
pp. 99-111 ◽  
Author(s):  
Wolfgang Löscher ◽  
Heidrun Potschka ◽  
Piotr Wlaź ◽  
Wojciech Danysz ◽  
Christopher G Parsons
Keyword(s):  
Drug Development ◽  
Antiepileptic Drug ◽  
Nicotinic Receptors ◽  
Development Studies ◽  
Neuronal Nicotinic Receptors ◽  
Seizure Models

scholarly journals Lipogenesis in Human Skin. III. Variation with Body Site

1963 ◽  
Vol 41 (4) ◽  
pp. 235-238 ◽  
Author(s):  
Robert D. Griesemer ◽  
Robert W. Thomas
Keyword(s):  
Human Skin ◽  
Body Site

Automated analytical systems for drug development studies. V. A system for enzyme kinetic studies

1996 ◽  
Vol 14 (12) ◽  
pp. 1691-1698 ◽  
Author(s):  
J. Zhou ◽  
E.C. Shearer ◽  
J. Hong ◽  
C.M. Riley ◽  
R.L. Schowen
Keyword(s):  
Drug Development ◽  
Kinetic Studies ◽  
Development Studies ◽  
Enzyme Kinetic

scholarly journals Human-on-a-chip design strategies and principles for physiologically based pharmacokinetics/pharmacodynamics modeling

2015 ◽  
Vol 7 (4) ◽  
pp. 383-391 ◽  
Author(s):  
Hasan Erbil Abaci ◽  
Michael L. Shuler
Keyword(s):  
Drug Development ◽  
Development Studies ◽  
Human Tissues ◽  
Design Strategies ◽  
Physiologically Based Pharmacokinetics ◽  
Microfluidic Platforms ◽  
Chip Design ◽  
Microphysiological Systems ◽  
Physiologically Based

Advances in maintaining multiple human tissues on microfluidic platforms has led to a growing interest in the development of microphysiological systems for drug development studies.

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