№ lp_1_2_24458
File format: docx Character count: 93893 File size: 3362 KB
The document outlines a guideline for assessing and controlling leachables in drug products, with an emphasis on risk management principles and materials characterization.
Year: 2025
Region / City: International
Subject: Pharmaceutical Guidelines
Document Type: Guideline
Organization / Institution: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author: ICH Expert Working Group
Target Audience: Regulatory authorities, pharmaceutical manufacturers
Period of Validity: Ongoing
Approval Date: 01 August 2025
Date of Modifications: N/A
Price: 8 / 10 USD
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