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Issue 13 ― Safety Pharmacology Guidelines and Practices: A Review
In this issue, we review safety pharmacology guidelines and practices.
Click here to download a PDF, readable version of Issue 13: https://www.altasciences.com/sites/default/files/2020-06/The%20Altascientist_issue13.pdf
Safety pharmacology studies are defined in the International Conference on Harmonization (known as the ICH) S7A guidance as “those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.” In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system.
CHAPTERS:
- 00:16 — Section 1: Key Considerations for Safety Pharmacology Studies
- 4:35 — Section 2: Core & Supplemental Studies
- 12:07 — Section 3: Species Selection
- 13:15 — Section 4: Number of Animals
- 14:06 — Section 5: Routes of Administration
- 14:29 — Section 6: Dose Level Selection & Duration
- 15:55 — Section 7: Supplemental Studies (aka Follow-Up Studies)
- 18:09 — Section 8: Safety Pharmacology Endpoints on Traditional Toxicology Studies
- 20:04 — Section 9: Safety Pharmacology Studies May Not be Necessary
- 20:45 — Section 10: Choosing a CRO for Safety Pharmacology Studies
- 21:40 — Conclusion
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
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By The Altascientist
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In this issue, we review safety pharmacology guidelines and practices.
Click here to download a PDF, readable version of Issue 13: https://www.altasciences.com/sites/default/files/2020-06/The%20Altascientist_issue13.pdf
Safety pharmacology studies are defined in the International Conference on Harmonization (known as the ICH) S7A guidance as “those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.” In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system.
CHAPTERS:
- 00:16 — Section 1: Key Considerations for Safety Pharmacology Studies
- 4:35 — Section 2: Core & Supplemental Studies
- 12:07 — Section 3: Species Selection
- 13:15 — Section 4: Number of Animals
- 14:06 — Section 5: Routes of Administration
- 14:29 — Section 6: Dose Level Selection & Duration
- 15:55 — Section 7: Supplemental Studies (aka Follow-Up Studies)
- 18:09 — Section 8: Safety Pharmacology Endpoints on Traditional Toxicology Studies
- 20:04 — Section 9: Safety Pharmacology Studies May Not be Necessary
- 20:45 — Section 10: Choosing a CRO for Safety Pharmacology Studies
- 21:40 — Conclusion
About Altasciences:
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.