Letter to the editor

Prasse, K. W.; Dodd, D. C.; Goodman, Dawn G.; Leader, R. W.; Ferrell, J. F.; Squire, Robert A.; Hardisty, Jerry F.; Newberne, James W.; Hildebrandt, Paul K.; Burek, J. D.; DePaoli, Alex M.; Boorman, Gary A.; Bendele, R.; Payne, Beverly D.; Ward, James M.; Todd, Glen C.; Webster, Henry deF.; Piper, R. C.; Patterson, Randolph E.

doi:10.1016/0041-008x(86)90336-4

Cited by 10 publications

(1 citation statement)

References 4 publications

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“…Examples of other techniques used to minimize observational bias are discussed in 8.4 and 8.5. There is a considerable consensus of opinion among toxicologic pathologists that implementation of masked evaluation during the initial evaluation of tissues can have a negative impact on both the time it takes to accomplish the microscopic evaluation as well as the quality of the information obtained from the study (Editorial SOTP, 1986;Goodman, 1988;House et al, 1992;Iatropoulos, 1984;Newberne and de la Iglesia, 1985;Prasse et al, 1986). There is a concern that masked evaluation makes the task of separating treatment-related changes from normal variation more difficult.…”

Section: The Process Of Histopathologic Evaluationmentioning

confidence: 99%

Best Practices Guideline: Toxicologic Histopathology

et al. 2004

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Section: The Process Of Histopathologic Evaluationmentioning

confidence: 99%

Best Practices Guideline: Toxicologic Histopathology

et al. 2004

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New pathway for qualification of novel methodologies in the European medicines agency

Manolis¹,

Vamvakas²,

Isaac³

2011

Proteomics Clinical Apps

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The European Medicines Agency (EMA) qualification process is a new, voluntary, scientific pathway leading to either a Committee for Medicinal Products for Human Use (CHMP) opinion or a Scientific Advice on innovative methods or drug development tools: (i) CHMP Qualification Opinion on the acceptability of a specific use of the proposed method, based on the assessment of submitted data and (ii) CHMP Qualification Advice on future protocols and methods for further method development towards qualification, based on the evaluation of the scientific rationale and on preliminary data submitted. The qualification procedure was established as a response to the drug development bottlenecks and inefficiencies, but also to the availability of new methodologies, not yet integrated in the drug development and clinical management paradigm. The qualification process addresses innovative methods developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry. It is expected to facilitate communication between the scientific community and the regulators and to address challenges with the development and use of medicines. In this article, we will present an overview of the process and the up to now scientific advice working party (SAWP) experience.

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Factors Affecting Histopathologic Interpretation of Toxicity—Carcinogenicity Studies

Goodman¹

1988

Carcinogenicity

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Letter to the editor

Cited by 10 publications

References 4 publications

Best Practices Guideline: Toxicologic Histopathology

Best Practices Guideline: Toxicologic Histopathology

New pathway for qualification of novel methodologies in the European medicines agency

Factors Affecting Histopathologic Interpretation of Toxicity—Carcinogenicity Studies

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