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 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 A European regulatory perspective on cystic fibrosis: current treatments, trends in drug development and translational challenges for CFTR modulators

2018 ◽  
Vol 27 (148) ◽  
pp. 170124 ◽  
Author(s):  
Stefano Ponzano ◽  
Giulia Nigrelli ◽  
Laura Fregonese ◽  
Irmgard Eichler ◽  
Fabio Bertozzi ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Drug Development ◽  
Forced Expiratory Volume ◽  
The European Union ◽  
End Points ◽  
Sweat Chloride ◽  
European Regulatory ◽  
Clinical Models ◽  
Cf Transmembrane Conductance Regulator ◽  
Cftr Modulators

In this article we analyse the current authorised treatments and trends in early drug development for cystic fibrosis (CF) in the European Union for the time period 2000–2016. The analysis indicates a significant improvement in the innovation and development of new potential medicines for CF, shifting from products that act on the symptoms of the disease towards new therapies targeting the cause of CF. However, within these new innovative medicines, results for CF transmembrane conductance regulator (CFTR) modulators indicate that one major challenge for turning a CF concept product into an actual medicine for the benefit of patients resides in the fact that, although pre-clinical models have shown good predictability for certain mutations, a good correlation to clinical end-points or biomarkers (e.g. forced expiratory volume in 1 s and sweat chloride) for all mutations has not yet been achieved. In this respect, the use of alternative end-points and innovative nonclinical models could be helpful for the understanding of those translational discrepancies. Collaborative endeavours to promote further research and development in these areas as well as early dialogue with the regulatory bodies available at the European competent authorities are recommended.

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 Biomarkers, Surrogate End Points, and the Acceleration of Drug Development for Cancer Prevention and Treatment

2004 ◽  
Vol 10 (11) ◽  
pp. 3881-3884 ◽  
Author(s):  
Gary J. Kelloff ◽  
Robert C. Bast ◽  
Donald S. Coffey ◽  
Anthony V. D’Amico ◽  
Robert S. Kerbel ◽  
...  
Keyword(s):  
Drug Development ◽  
Cancer Prevention ◽  
End Points ◽  
Prevention And Treatment

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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