Use of Classical Pharmacokinetic Evaluations in Drug Development and Safety Assessment

2016 ◽  
pp. 95-122
Author(s):  
Rakesh Dixit ◽  
Peter Ward
Keyword(s):  
Drug Development ◽  
Safety Assessment

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.

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

2021 ◽  
Author(s):  
Barbara A. Hendrickson ◽  
William Wang ◽  
Greg Ball ◽  
Dimitri Bennett ◽  
Amit Bhattacharyya ◽  
...  
Keyword(s):  
Life Cycle ◽  
Drug Development ◽  
Safety Assessment ◽  
Development Life Cycle

Kidney Safety Assessment: Current Practices in Drug Development

2019 ◽  
Vol 39 (2) ◽  
pp. 120-131 ◽  
Author(s):  
Sean P. Troth ◽  
Frank Simutis ◽  
Gary S. Friedman ◽  
Susan Todd ◽  
Frank D. Sistare
Keyword(s):  
Drug Development ◽  
Safety Assessment ◽  
Current Practices

scholarly journals Reducing attrition in drug development: Smart loading pre-clinical safety assessment

2014 ◽  
Vol 229 ◽  
pp. S167
Author(s):  
Stefan Kavanagh ◽  
Howard Mellor ◽  
Christopher Pollard ◽  
Sally Robinson ◽  
Stefan Platz ◽  
...  
Keyword(s):  
Drug Development ◽  
Safety Assessment ◽  
Clinical Safety

scholarly journals Perspectives From the 12th Annual Minipig Research Forum: Early Inclusion of the Minipig in Safety Assessment Species Selection Should be the Standard Approach

2019 ◽  
Vol 47 (7) ◽  
pp. 891-895 ◽  
Author(s):  
Keith Jones ◽  
Joanna Harding ◽  
Andy Makin ◽  
Pramila Singh ◽  
Björn Jacobsen ◽  
...  
Keyword(s):  
Drug Development ◽  
Small Molecules ◽  
Biomedical Research ◽  
Safety Assessment ◽  
Scientific Data ◽  
Species Selection ◽  
Selection Strategy ◽  
Early Screening ◽  
Development Stages ◽  
Regulatory Guidelines

Over the last decade, the minipig has been established as a species which can be used in biomedical research, including drug development safety assessment. There are no mandatory regulatory guidelines regarding species selection strategy for safety assessment; hence, choice is at the discretion of companies responsible for drug development. A survey of member companies by IQ DruSafe (2016) highlighted inconsistent and low use of the minipig. At the 12th Annual Minipig Research Forum in 2018, presentations and a workshop examined current practices and considered if the minipig could be utilized more from earliest drug development stages. Despite the agreed utility of scientific data and validity of the minipig, especially for small molecules, each company has its own approach in nonrodent species selection, without consistent rationale. The overall objective should be to ensure the most appropriate species is selected and is scientifically based, with the minipig systematically included from early screening stages.

scholarly journals Reducing attrition in drug development: smart loading preclinical safety assessment

2014 ◽  
Vol 19 (3) ◽  
pp. 341-347 ◽  
Author(s):  
Ruth A. Roberts ◽  
Stefan L. Kavanagh ◽  
Howard R. Mellor ◽  
Christopher E. Pollard ◽  
Sally Robinson ◽  
...  
Keyword(s):  
Drug Development ◽  
Safety Assessment ◽  
Preclinical Safety

Pigs and Ferrets as Models in Toxicology and Biological Safety Assessment

2000 ◽  
Vol 19 (3) ◽  
pp. 149-168 ◽  
Author(s):  
Shayne C. Gad
Keyword(s):  
Animal Models ◽  
Drug Development ◽  
Safety Assessment ◽  
Key Factors ◽  
Biological Safety

Both the pig and the ferret are used as animal models in toxicology and drug development, with the pig having been subject to a significant increase in usage (particularly in Europe) over the last 5 years. These two species are quite different from primates and dogs, the “standard” nonrodent models. This article seeks to both survey the rationales for and extent of use of the pig and ferret, and to highlight consideration and key factors in their use in studies.

Sign in / Sign up

Export Citation Format

Share Document