This article explores how digital maturity in process design and parameter management can drive significant time and cost ...

FDA proposes draft guidelines on AI use in drug development, addressing challenges and opportunities for improving safety and ...

ANOVA - a robust statistical tool for determining intermediate precision in analytical method validation: K. Sadasivan Pillai Wednesday, February 12, 2025, 08:00 Hrs [IST] In the ...

Union Minister of State for Health and Family Welfare, Anupriya Patel, delivered the keynote address at the 15th ...

You have full access to this article via your institution. Figure 1: Density of actively recruiting clinical sites of biopharmaceutical clinical trials worldwide. Assessing the regional ...

India’s leadership in pharmacopoeial standard setting is commendable, said Dr. Roderico H. Ofrin, WHO Representative to India, on Wednesday. Ofrin also stressed the importance of regulatory ...

Union Minister Anupriya Patel delivered the keynote at the 15th IMWP, stressing India's commitment to pharmaceutical standardisation. The meeting, bringing together international leaders, focused on ...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the ICH E6(R3) draft guideline for public consultation in May 2023 in ...

Continuous manufacturing (CM) has become a contentious topic in the modern pharmaceutical lexicon, driven by divergent ...

Additionally, Korea also follows the Korean Good Clinical Practice guidelines (KGCP), which is harmonised to the International Conference on Harmonisation Good Clinical Practice (ICH GCP ...