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198 Module 8 PHARMACOLOGY REVIEW INTRODUCTION This module is not intended as a substitution for a medication or drug handbook, but rather as a brief, overall review of medications. We strongly encourage
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Module 8 pharmacology review is a comprehensive review of the pharmacological aspects of a drug, including its mechanism of action, pharmacokinetics, and potential side effects.
All pharmaceutical companies seeking approval for a new drug or a new indication are required to file module 8 pharmacology review.
Module 8 pharmacology review is typically filled out by a team of pharmacologists and drug safety experts within the pharmaceutical company, following regulatory guidelines and providing detailed information on the drug's pharmacological profile.
The purpose of module 8 pharmacology review is to assess the safety and efficacy of a drug's pharmacological properties, helping regulatory authorities make informed decisions regarding its approval.
Module 8 pharmacology review must include detailed information on the drug's mechanism of action, pharmacokinetics, pharmacodynamics, potential side effects, and any relevant preclinical and clinical data.
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