Status of Safety Pharmacology and Present Guidelines

Reference work entry

Abstract

Ray Lipicky (Director, LIPICKY, LLC, A Consulting Company; retires from FDA in February 2002) started one of his presentations with the following slide:

Keywords

Pharmacodynamic Effect Ventricular Repolarization Human Safety Safety Pharmacology Major Organ System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References and Further Reading

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Online Links

  1. E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (Step 5, May 2005). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/Step4/E14_Guideline.pdf
  2. E14 Implementation Working Group Questions & Answers (Current Version June 2008). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/Q_As/E14_Q_As_step4pdf.pdf
  3. Final Concept Paper E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Additional Q & As document (Endorsed by the Steering Committee, April 2010). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/Q_As/E14_Q__As_Final_Concept_Paper_March_15_2010x.pdf
  4. M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (Step 5; June 2009). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf
  5. M3(R2) Implementation Working Group on the M3(R2) Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (Current version June 2011). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Q_As/ M3_R2_Q_AStep4.pdf
  6. Points to Consider on the Assessment of the Potential for QT Interval Prolongation by Non-Cardiovascular Medicinal Products; CPMP/SWP/986/96; published December 1997; replaced by ICH S7A and taken off EMEA websiteGoogle Scholar
  7. S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Step 5, July 1997). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Step4/S6_R1_Guideline.pdf
  8. Final Concept Paper S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Revision of the ICH S6 Guideline) (Endowed by the Steering Committee, June 2008). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Concept_papers/S6_R1__Concept_Paper.pdf
  9. S7A: Safety Pharmacology Studies for Human Pharmaceuticals (Step 5, November 2000). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S7A/Step4/S7A_Guideline.pdf
  10. S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (Step 5, May 2005). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S7B/Step4/S7B_Guideline.pdf
  11. Final Concept Paper S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (Endorsed by the Steering Committee, May 2001). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S7B/Concept_papers/S7B_Concept_Paper.pdf
  12. S9: Nonclinical Evaluation for Anticancer Pharmaceuticals (Step 5, October 2009). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Business Development ConsultantCorDynamicsDieburgGermany

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