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IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.

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US Woman Receives Revolutionary Brain Implant For OCD And Epilepsy

AuroBlog - Aurous Healthcare Clinical Trials blog

American Amber Pearson used to wash her hands until they bled, terrified by the idea of contamination from everyday items, a debilitating result of her obsessive compulsive disorder (OCD).

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J&J Sues Baby Powder Researchers Over “Junk Litigation Opinions”

XTalks

The drugmaker is facing more than 38,000 talc-related lawsuits, mostly over its iconic baby powder which plaintiffs claim was contaminated with asbestos that caused ovarian cancer and mesothelioma. LTL is also asking the court to force the researchers to disclose the patients’ identities, according to Reuters.

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GxP Best Practices for Safer, Smarter, Faster Clinical Research

Advarra

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Decentralized Clinical Trials in a Post-Pandemic Era

ACRP blog

Overview Decentralized clinical trials (DCTs) represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. Only about 5% of eligible patients enroll in clinical trials, with minority populations representing an even lower percentage. [x]

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Reducing Environmental Impact in Clinical Trials: Best Sustainable Practices

Cloudbyz

Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Clinical trials, in particular, have a significant impact on the environment, and it is essential to address this impact to ensure a sustainable future.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.