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. The experience gathered till now seems to be enough to start considering a harmonization process.
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 planning of systems, contributing to transparency and data integrity.
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 to new technologies, and potential monopolies. In the pharmaceutical industry, patents are crucial for protecting innovations, but they can also be an obstacle to developing equivalent products.
Read all about patents in the industry.
Sampling and Resampling Methods
One of the essential problems in the management of data is the obtention of a sample using an objective and scientific approach. Several procedures exist and are reliable to that purpose.
Technology and Health
Advances in technology have expanded medical treatment options and have also transformed the way professionals perform their jobs.
WOMEN’S MONTH
During the month of March, the struggle of Women to overcome the social inequality attributable to gender is celebrated.
Revolution of personalized medicines
The advancement of precision medicine brings us closer to more precise, predictable and personalized medical care for the patient.
About Vaccines
Vaccination not only protects those who have received a vaccine, but also those around them.
Cleaning validation in patch manufacturing
Cleaning validation is a procedure of establishing evidence that cleaning processes for manufacturing equipment prevent product contamination
Search for alternative methods for animal experimentation
In recent years, laboratories have been investigating new alternatives to eliminate or avoid animal testing of cosmetic and medical products.