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BIOLOGICAL INVESTIGATIONS A HANDBOOK for BIO 110 and beyond Lewis & Clark Collegiate:___Section:___120232024 edition (revised Sept. 3 2023)Table of Contents TABLE OF CONTENTS ..........................................................................................2 FOREWORD
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Biological investigations are studies or assessments aimed at understanding biological processes, organisms, or effects, typically related to environmental health, safety, or regulatory compliance.
Entities involved in research and development, manufacturing, or distribution of biological products, as well as regulatory bodies, are required to file biological investigations.
Biological investigations must be filled out by gathering relevant data, completing required forms accurately, and submitting them to the appropriate regulatory authority for review.
The purpose of biological investigations is to ensure safety and efficacy of biological products, assess potential risks, and support compliance with health regulations.
Relevant information that must be reported includes study methodologies, results, product specifications, safety data, and any adverse effects observed.
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