While the use of pharmaceuticals is always a balance of risks and benefits, the same is not true for impurities in pharmaceuticals; impurities convey only risk. A number of international guidelines and regional guidances instruct drug developers and regulatory agencies on how to evaluate and control impurities in drug substances and drug products. While impurities should always be reduced to th...

Reverse micelle extraction has received considerable attention in recent years due to its ability to selectively solubilise solutes from an aqueous phase and to maintain their biological activities. This paper presents the results from studies on extraction of penicillin G from aqueous solution (forward extraction) and from reverse micelles to a new aqueous solution (backward extraction), by em...

Understanding physician behaviour is always critical for marketers of pharmaceutical companies.. These days different brands are in the field, increasing the size of the market. In this competition medical practitioner and physician are the key customers for this industry. Thus they are the prime focus for the marketing strategy. Product, price and promotion are the key ingredients where the ma...

At FDA as well as industry, we promote powerful test with type I error rate controlled. It leads to various tests using different standard error or confidence interval. We often ignored that the confidence interval should be consistent with the test. It happens also often in equivalence testing when 90% confidence interval is used to decide if the two treatments are equivalent. I examined cases...

ABOUT THE AUTHORS Deliang Zhou, Ph.D., is a principal pharmaceutical scientist in Oral Drug Products, Manufacturing Science & Technology at Abbott Laboratories. He may be reached at [email protected]. Yihong Qiu, Ph.D., is a research fellow and associate director in Global Pharmaceutical Regulatory Affairs CMC, Global pharmaceutical R&D at Abbott Laboratories. He may be reached at qiu.yih...