Innovation in safety pharmacology testing
Autor: | David J. Gallacher, Michael J. Curtis, Michael K. Pugsley, Simon Authier, Rob Towart |
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Rok vydání: | 2011 |
Předmět: |
Pharmacology
education.field_of_study Drug-Related Side Effects and Adverse Reactions business.industry Safety pharmacology education Population Drug Evaluation Preclinical Theory to practice First in human Toxicology New chemical entity Toxicity Tests Abuse liability Humans Medicine Profiling (information science) Engineering ethics business Biological sciences |
Zdroj: | Journal of Pharmacological and Toxicological Methods. 64:1-6 |
ISSN: | 1056-8719 |
Popis: | This issue of the Journal of Pharmacological and Toxicological Methods (JPTM) is themed. It is the eighth in a series, arising from the Annual Safety Pharmacology Society (SPS) meeting. The SPS is now in its 10th year as an independent branch of biological sciences (distinct from pharmacology and toxicology) and is the primary forum for driving advances in safety pharmacology. The theme of the meeting and this journal issue is innovation, and the focus is non-clinical safety assessment of new chemical entity (NCEs). The content is informed by regulatory guidance documents (S7A and S7B) prior to first in human (FIH) studies. The manuscripts cover a broad spectrum of safety pharmacology topics from theory to practice, with interrogation of state-of-the-art techniques, and profiling of methods that are in development for safety assessment. Philosophical and strategic issues are addressed, with consideration of the use of novel methods for population pharmacokinetic (PK) analysis, abuse liability, electrocardiogram (ECG) analysis algorithms, in vitro cardiac slice preparations, human pluripotent stem cells, and a brief discussion regarding the assessment of changes in the QRS complex of the ECG indicative of drug-induced blockade of cardiac sodium channels. Safety pharmacology methods continue to evolve. |
Databáze: | OpenAIRE |
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