Non-Clinical Health & Environmental Safety Studies

🌱 Visnova Insights: Ensuring Safety Beyond the Clinic – The Role of Non-Clinical Health & Environmental Safety Studies

📘 Introduction

In pharmaceutical and agrochemical research, non-clinical health and environmental safety studies are essential. They ensure that new drugs and chemicals are safe for both human and environmental health—before they ever reach clinical trials. These studies follow Good Laboratory Practice (GLP) to guarantee scientific accuracy and regulatory compliance.

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🔬 Table 1: Overview of Non-Clinical Safety Studies

Purpose	Examples	Outcome/Use
Identify toxic effects	Acute, sub-chronic, chronic toxicity tests	Determine organ-specific toxicity
Establish exposure limits	Dose-response studies	Identify NOAEL (No-Observed-Adverse-Effect Level)
Study metabolism and kinetics	ADME studies (Absorption, Distribution, Metabolism, Excretion)	Understand drug movement and breakdown
Reproductive & developmental toxicity	Fertility, embryo-fetal development studies	Evaluate impact on reproduction
Genetic toxicity	Ames test, Micronucleus test	Detect potential mutagenic properties

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🌍 Table 2: Types of Environmental Safety Studies

Study Type	Key Focus	Measured Parameters	Significance
Environmental Fate	Degradation in soil, water, air	DT50, DT90, Half-life	Predicts persistence in environment
Ecotoxicology	Effect on fish, daphnia, algae	LC50, EC50, NOEC	Assesses toxicity to non-target organisms
Bioaccumulation	Chemical accumulation in living tissues	BAF, BCF	Estimates long-term ecological risk
Mobility in Soil	Movement of substance through soil	Koc (Adsorption Coefficient)	Evaluates groundwater contamination risk

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🏛 Table 3: GLP Regulatory Compliance Across Regions

Region	Regulatory Authority	GLP Guidelines Followed	Applicable Sectors
USA	US FDA, US EPA	21 CFR Part 58, FIFRA GLP Rules	Pharma, Environment, Pesticides
Europe	EMA, ECHA	OECD Principles of GLP	Pharma, Agrochemicals
India	NGCMA (DSIR), MoEFCC	OECD-GLP via NABL recognition	Pharma, Agrochemicals, Environment
Japan	PMDA, MHLW	OECD GLP + Local Ministry Guidelines	Pharmaceuticals

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🧩 Table 4: Visnova’s Support for Non-Clinical Studies

Area of Expertise	Services Provided	Target Clients
Lab Setup & Infrastructure	Layout planning, Equipment selection, Documentation	New CROs, QA Units
GLP Training	SOP writing, QA/QC training, GLP documentation practices	Analysts, Study Directors, QA personnel
Regulatory Documentation	Study plan design, Report formatting, Archival guidance	CROs, Regulatory teams
Mock Audits & Prechecks	Compliance review, Gap analysis, Remedial actions	Labs seeking NABL/OECD certification

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📣 Connect with Visnova

For consultations, training, or lab setup in non-clinical and environmental safety testing:

📧 Email: poornachandrashetty@visnovacom.com
🌐 Website: Coming Soon!