All articles by ramachandrudu mangali
ramachandrudu mangali
Understanding excipients
Excipients and the effect they have on the quality of small molecules is a complex subject. Sally Turner speaks to Dr David Elder, former director of CMC due diligence at GSK, about some of the common challenges that occur during excipient selection, including labelling and safety, alignment of risk-based guidance, biowaivers, the inactive ingredient list, and the diffi culties around novel excipients and safety collaborations.
The analytics angle
Data management and business value serialisation can create a wealth of data, but the challenges of storing and maintaining the integrity of this data is no simple task. World Pharmaceutical Frontiers examines the best approaches to data management, and how it can add value to an organization through information sharing and employing analytics to guide strategic business decisions.
Waste not, want not: enhancing clinical trial supply chain efficiency
The problem of inefficient trial supply chain practices costs operators millions every year in unused equipment and merchandise. Alex Robertson, senior director of supply chain management at AstraZeneca, explores how to develop strategies to optimise supply, drive efficiency and reduce waste in modern trials.
Make up the numbers: patient recruitment for clinical trials
There are only a finite number of patients available in the world to recruit for a clinical trial. How do you go about getting them into your trial and, once you do, how do you make sure the trial is run efficiently and using the best new technology? Andrew Putwain speaks to Subrata Bose, head of feasibility operations and recruitment strategy at Bayer, about this issue.
Sticky problem: challenges of proper packaging and labelling of clinical supplies
Correct packaging and labelling of investigational medicinal products are essential for guaranteeing regulatory compliance, minimising error-related costs and, most importantly, ensuring the safety of participants. Percy Ledger looks at the challenges involved, as well as how technology can improve the process.
