Shaping the future of pharma
Email: info@amarintech.com.ar
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 [...]
New tools for more precise drug delivery systems Kimbelery Pardo – Marketing and Business Development Analyst The pharmaceutical industry is undergoing a period of profound transformation driven by the convergence of materials science, biology, and technology. In this context, smart biomaterials and nanotechnology are emerging as key tools for the [...]
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 [...]
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. [...]
In the pharmaceutical industry, the validation of computerized systems is a regulatory requirement, not an optional best practice. Every system with an impact on the GxP environment — Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice — must comply with applicable quality standards and be properly documented. Without this, [...]
The transportation of psychotropics within the pharmaceutical supply chain is one of the most regulated and operationally complex logistics processes in the sector. The reasons are well known: these substances act on the central nervous system, carry high diversion and abuse potential, and require storage conditions and traceability standards that [...]
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 [...]
Ensuring adhesion throughout the use of a medicinal patch is crucial for providing safe and reliable products. Discover how an adhesive overlay can be the solution to adhesion problems and the challenges its formulation presents. From compatibility with the active ingredient to the ideal size and the ability to avoid [...]
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 [...]