Category: Sin categoría
The boom in complex generics is reshaping pharmaceutical development needs
The pharmaceutical industry is undergoing a significant transformation driven by the growth of complex generics, a category of medicines that…
Chemical reverse engineering for identifying unknown impurities and solving complex problems
In sectors such as pharmaceuticals, chemicals, cosmetics, and food production, the appearance of unexpected product failures can lead to significant…
USP 661.2: The Growth Driver of Extractables and Leachables
Impact of USP 661.2 on the Pharmaceutical Industry The pharmaceutical and biotechnology sector is undergoing a key transformation driven by…
Complex generics development in the European environment with new challenges and opportunities
The development of complex generics has become one of the most strategic areas of the pharmaceutical industry in Spain and…
How the ICH M7 guideline regulates genotoxic impurities in the pharmaceutical industry
The ICH M7 guideline establishes the international framework for controlling genotoxic impurities such as nitrosamines and NDSRIs in medical products….
Strengthening Control of Mutagenic Impurities and Nitrosamines (NDSRI) in the Pharmaceutical Industry
International regulations on mutagenic impurities and nitrosamines in medicines have entered a phase of increased technical stringency. They focus especially…
Fundamentals of pharmaceutical lyophilization: Everything you need to know
The fundamentals of pharmaceutical lyophilization are based on the removal of water through sublimation under controlled temperature and vacuum conditions….
Galenical or Analytical Consulting? Benefits of Each and How They Complement Each Other
Galenical and analytical consulting provide a comprehensive approach to the development of pharmaceutical, cosmetic, and medical products. While galenical consulting…
How stability studies are conducted and what information they provide about a product
Stability studies evaluate how a product maintains its properties over time when exposed to environmental factors such as temperature, light,…
What are Good Laboratory Practices (GLP) and why are they key to reliable results?
Good laboratory practices (GLP): Key to ensuring reliable and reproducible results Good laboratory practices (GLP) are a set of principles…
