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Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...

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Humans continually engage with an environment rich in potentially harmful chemicals. These are introduced to our bodies through inhalation, ingestion, or skin contact. These chemicals exist in various forms, such as air and environmental pollutants, agricultural chemicals, organic solvents, and heavy metals.
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Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Related Experiment Video

Updated: Sep 14, 2025

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Errors in toxicology testing and the need for full discovery.

Aaron Olson¹, Charles Ramsay²

¹ARO Consulting LLC, PO Box 132, Hugo, MN, 55038, USA.

Forensic Science International. Synergy

|July 24, 2025

Summary

This summary is machine-generated.

Toxicology errors, ranging from technical failures to misconduct, have impacted thousands of criminal justice cases for years. Reforms like transparency and audits are crucial for scientific integrity and justice.

Keywords:

Breath alcohol testing Calibration errors Discovery violations Laboratory misconduct Source code Toxicology errors Whistleblower retaliation

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Area of Science:

Forensic Toxicology
Analytical Chemistry
Criminal Justice

Background:

Toxicology, grounded in analytical chemistry, faces significant error risks impacting legal outcomes.
This review analyzes 48 years of toxicology errors across jurisdictions.

Discussion:

Errors identified include traceability issues, calibration failures, discovery violations, maintenance problems, source code defects, fraud, interfering substances, reporting mistakes, lab contamination, and chain of custody breaches.
Many errors persisted for years, often detected externally rather than through internal quality control.
Patterns observed include institutional non-disclosure, whistleblower retaliation, and withholding of exculpatory evidence.

Key Insights:

Toxicology laboratories exhibit systemic vulnerabilities.
Errors span technical malfunctions to deliberate misconduct, affecting numerous cases.
External detection and institutional resistance to disclosure are significant concerns.

Outlook:

Reforms are essential, including online discovery portals for transparency, mandatory digital data retention, and independent lab accreditation.
Whistleblower protections and regular third-party audits are vital.
Learning from past errors can prevent future mistakes, enhancing forensic science and justice.