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Amarin_SweatManagement

Effective sweat management as a key factor for the medicinal patch success

Effective sweat management is crucial for the success of medicinal patches, as it impacts both their adhesion and patient safety. Sweat accumulation at the patch-skin interface can compromise therapeutic efficacy by causing the patch to detach prematurely, preventing the release of the required drug dose. Additionally, prolonged moisture can lead [...]

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Amarin_Interchangeability_Guidance_for_TDS

Interchangeability Guidances for TDS, Need for Harmonization

Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process. There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. [...]

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Amarin_Validation_of_Computerized_Systems

Validation of Computerized Systems – Guide to Preparing the Systems Inventory

In the pharmaceutical industry, computerized systems impacting GxP environments must adhere to strict regulations to ensure product quality and patient safety. A documented inventory is essential for controlling these systems, identifying their GxP impact, and assessing their associated risk levels. This inventory supports regulatory compliance, facilitates audits, and enables strategic [...]

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Amarin_safe_transportation_of_Psychotropics

Safe Transportation of Psychotropics in the Pharmaceutical Industry

The transportation of psychotropics within the pharmaceutical industry is a complex and highly regulated process due to their potential for abuse and impact on health. These medications require specialized handling and compliance with international and local regulations, including permits and comprehensive tracking of product movement. Key challenges include regulatory compliance, [...]

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Intellectual Property in Pharmaceutical Products and Development Strategies

Since the Modern Age, creative individuals and entrepreneurs have sought to protect their inventions through patents, gaining legal advantages to capitalize on their ideas. Obtaining a patent grants exclusive rights, competitive advantages, and the possibility of generating income. However, it also presents challenges such as high costs, restrictions on access [...]

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The Critical Role of the Microbiome in Neurodegenerative Diseases: Perspectives and Challenges

Discover the critical role of the microbiome in neurodegenerative diseases and the challenges facing current research. This blog explores the significance of the gut-brain connection, the bidirectional operation of the Central Nervous System-Gut-Microbiota axis, and the implications for conditions like Parkinson's and Alzheimer's. Despite emerging concerns about research validity, there [...]

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Ethical Alternatives in Research

Advances in ethical alternatives to animal experimentation, such as in vitro models and the implementation of the "3R" principle, show a growing commitment to animal welfare, improving research quality, and protecting the environment. These practices offer more relevant results for humans while addressing ethical and scientific concerns. Integrating humane and [...]

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