Transformando el futuro de la industria farmacéutica
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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, 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 [...]
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 [...]
Cleaning validation is a procedure of establishing evidence that cleaning processes for manufacturing equipment prevent product contamination [...]
In recent years, laboratories have been investigating new alternatives to eliminate or avoid animal testing of cosmetic and medical products. [...]
The correct adhesion of a transdermal patch to skin throughout the established time of use is key to guarantee the effective administration of the dose declared in the prescribing information. [...]
The production of transdermal patches is a continuous and artisanal process that consists of 3 stages that reflect how delicate and specific is the production of this niche pharmaceutical form. Let´s review it! [...]
Far away, in 1979, the first transdermal patch to reach the market, produced under an industrial controlled process and backed by clinical studies, was launched in US under the brand name TransderScop®. [...]
The Latin American surveillance health authorities have made progress year after year with respect to the requirements of product registration in general, seeking the best balance between the safety of its inhabitants, the efficacy of the products and the economic reality of each country. [...]