Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with API and are therefore unique to every APIs. Drug products containing API that have 2° or 3° amines, when mixed with excipients that have the ability to cause the nitrosation reaction, are responsible for the formation of NDSRIs. There is often a lack of mutagenicity […]
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Navigating through API requirements to successfully register a drug product can be challenging, especially when these requirements are embedded in drug product regulations. This was indeed the case for Brazil where rules and regulations for APIs were very much available but were unclear as they formed a part of the drug product regulations rather than
Mandating CADIFA for drug registration in Brazil Read More »
The Center for Drug Evaluation and Research (CDER) of the US FDA outlined a program in February 2019 in which various stakeholders of the industry could propose pharmaceutical quality standards for recognition by the CDER. This would provide the industry with additional resources for the development and manufacturing of pharmaceuticals. In July 2023, the CDER
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The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,
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In a world where women’s health and autonomy are of utmost importance, ensuring diverse and accessible contraceptive options has become a pressing priority. In response to evolving societal demands, the call for inclusive and non-prescriptive contraceptive solutions has emerged, allowing individuals to take control of their reproductive health, irrespective of their background or circumstances. The
Enhancing Accessibility to Contraceptives through Rx-to-OTC switch Read More »
The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) plays a crucial role in verifying the quality standards of active pharmaceutical ingredients (APIs). Issued by the European Directorate for the Quality of Medicines (EDQM), the CEP serves as evidence that an API complies with the rigorous quality requirements outlined in
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The use of real-world data (RWD) and real-world evidence (RWE) in Life Sciences and Pharma is significantly gaining recognition for the value it brings in making enhanced regulatory decisions. The evaluation of pharmaceuticals throughout their development and lifecycle is a complex process that requires robust evidence to ensure their safety and effectiveness. Traditionally, randomized clinical
ICH: An Approach to Harmonizing Real World Data & Real World Evidence Read More »
Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)
US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs Read More »
In this new era, where different therapeutic realms converge, the emergence of combination products has revolutionized the healthcare landscape by providing more innovative treatment options to treat the unmet medical needs of patients. However, with great power comes great responsibility. Continuously monitoring these products and ensuring they are safe to use is paramount in order
US FDA: Safety Reporting Requirements for Combination Products Read More »
Complex drugs add more value to patients compared to simple generics as they are capable of addressing unmet needs of patients for particular conditions. However, biopharmaceutical companies encounter distinctive hurdles when it comes to the advancement of complex generic drugs. These medications, known for their intricate characteristics or the requirement of additional clinical trials, necessitate
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