Shaping the future of pharma
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The regulatory landscape of pharmaceutical development continues to evolve, and recent updates from the US Food and Drug Administration (FDA) highlight how companies will need to adapt their documentation and quality strategies in the coming years. The FDA has released a draft revision of the Common Technical Document (CTD) Quality [...]
Since the beginning of the Modern Age, inventors and companies have sought to protect their innovations through patents — the legal instrument granting temporary exclusivity over their developments. In the pharmaceutical industry, this mechanism carries particular weight: research cycles are long, regulatory approval costs are high, and the commercial exclusivity [...]
The relationship between the gut microbiome and neurodegenerative diseases is one of the most actively researched fields of the past decade. Accumulated preclinical and clinical evidence suggests the microbiota may play a key role in susceptibility to and progression of conditions such as Parkinson's and Alzheimer's disease. At the same [...]
In recent years, the pharmaceutical and life sciences industry has intensified its search for alternatives to animal experimentation. This trend responds to three simultaneous pressures: growing concern for animal welfare, scientific doubts about the validity of extrapolating animal data to humans, and the increasing availability of alternative methodologies yielding more [...]
Transdermal patches have come a long way since their introduction in 1979. However, unlike other pharmaceutical forms, they never achieved massive market penetration: between 2015 and 2022, the FDA approved only 84 transdermal patches out of a total of 7,239 generic products, representing just 1.2% of the total. The reason [...]
The scientific communication system we use today is the result of centuries of evolution. Understanding how we got here — and where the system has failed — is relevant for any team that uses scientific evidence as the basis for development decisions. [...]
Work-related accidents pose a constant concern in the industry, where the safety and well-being of employees are paramount. In this article, we will explore the crucial measures that must be implemented to prevent accidents, the responsibilities of companies, and the tools available to ensure a safe work environment. [...]
According to the World Health Organization, the abusive consumption of certain drugs and substances has increased in recent years, resulting in serious consequences for the population, including neurological damage, motor disabilities, addiction, overdoses, and even death. While traditional pharmaceutical forms such as tablets are frequently abused, transdermal patches, especially those [...]
Transdermal patches present specific attributes that determine their efficacy, safety, and quality, and that must be controlled in the laboratory through analytical techniques to ensure the performance and safety of the transdermal delivery system (TDS). Some correspond to tests common to other pharmaceutical forms. However, due to the particular characteristics [...]
In the pharmaceutical business, supply chain management plays a fundamental role in delivering the necessary raw materials for the production of safe pharmaceutical forms intended for patients and end consumers. It also involves the precise and timely coordination of finished products not only for the domestic market but also for [...]