Toxicologic pathology in the 21st century.

Toxicology is and will be heavily influenced by advances in many scientific disciplines. For toxicologic pathology, particularly relevant are the increasing array of molecular methods providing deeper insights into toxicity pathways, in vivo imaging techniques visualizing toxicodynamics and more powerful computers anticipated to allow (partly) automated morphological diagnoses. It appears unlikely that, in a foreseeable future, animal studies can be replaced by in silico and in vitro studies or longer term in vivo studies by investigations of biomarkers including toxicogenomics of shorter term studies, though the importance of such approaches will continue to increase.

Successful drug development despite adverse preclinical findings part 2: examples.

To illustrate the process of addressing adverse preclinical findings (APFs) as outlined in the first part of this review, a number of cases with unexpected APF in toxicity studies with drug candidates is discussed in this second part. The emphasis is on risk characterization, especially regarding the mode of action (MoA), and risk evaluation regarding relevance for man. While severe APFs such as retinal toxicity may turn out to be of little human relevance, minor findings particularly in early toxicity studies, such as vasculitis, may later pose a real problem.

Successful drug development despite adverse preclinical findings part 1: processes to address issues and most important findings.

Unexpected adverse preclinical findings (APFs) are not infrequently encountered during drug development. Such APFs can be functional disturbances such as QT prolongation, morphological toxicity or carcinogenicity. The latter is of particular concern in conjunction with equivocal genotoxicity results.

International recommendations for training future toxicologic pathologists participating in regulatory-type, nonclinical toxicity studies.

The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type nonclinical toxicology studies. Trainees optimally should undertake a scientific curriculum of at least 5 years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). Trainees should then obtain 4 or more years of intensive pathology practice during a residency and/or on-the-job "apprenticeship," at least 2 years of which must be focused on regulatory-type toxicologic pathology topics.

International recommendations for training future toxicologic pathologists participating in regulatory-type, nonclinical toxicity studies.

The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type - nonclinical toxicology studies. Trainees optimally should undertake a scientific curriculum of at least 5 years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). Trainees should then obtain 4 or more years of intensive pathology practice during a residency and/or on-the-job "apprenticeship," at least 2 years of which must be focused on regulatory-type toxicologic pathology topics.

International recommendations for training future toxicologic pathologists participating in regulatory-type, nonclinical toxicity studies.

The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type, nonclinical toxicology studies. Optimally, trainees should undertake a scientific curriculum of at least five years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). Trainees should then obtain four or more years of intensive pathology practice during a residency and/or on-the-job "apprenticeship," at least two years of which must be focused on regulatory-type toxicologic pathology topics.

Global recognition of qualified toxicologic pathologists: credential review as a potential route for recognizing the proficiency of pathologists involved in regulatory-type nonclinical studies.

Recent international summits of the International Federation of Societies of Toxicologic Pathologists (IFSTP) have debated the desirability and potential means by which the proficiency of an individual toxicologic pathologist might be recognized and communicated throughout the world. The present document describes the advantages and disadvantages of implementing such a global recognition system by any means, and provides a proposal whereby recognition might be accorded via rigorous credential review of a practitioner's education and experience.

Global Recognition of Qualified Toxicologic Pathologists: Credential Review as a Potential Route for Recognizing the Proficiency of Pathologists Involved in Regulatory-type Nonclinical Studies.

Recent international summits of the International Federation of Societies of Toxicologic Pathologists (IFSTP) have debated the desirability and potential means by which the proficiency of an individual toxicologic pathologist might be recognized and communicated throughout the world. The present document describes the advantages and disadvantages of implementing such a global recognition system by any means, and provides a proposal whereby recognition might be accorded via rigorous credential review of a practitioner's education and experience.

Global recognition of qualified toxicologic pathologists: credential review as a potential route for recognizing the proficiency of pathologists involved in regulatory-type nonclinical studies.

Recent international summits of the International Federation of Societies of Toxicologic Pathologists have debated the desirability and potential means by which the proficiency of an individual toxicologic pathologist might be recognized and communicated throughout the world. The present article describes the advantages and disadvantages of implementing such a global recognition system by any means and provides a proposal whereby recognition might be accorded via rigorous credential review of a practitioner's education and experience.

Global recognition of qualified toxicologic pathologists: where we are now and where we need to go.

Although there are a few national schemes for accreditation/certification of toxicologic pathologists (e.g., in Japan and the United Kingdom), a global recognition system for bench toxicologic pathologists is missing, as are universal standards defining their core competencies.

Global recognition of qualified toxicologic pathologists: where we are now and where we need to go.

While there are a few national schemes for accreditation/certification of toxicologic pathologists (e.g. in Japan and UK), a global recognition system for bench toxicologic pathologists is missing, as are universal standards defining their core competencies.