Integration of Risk Assessment into CMC Application Review


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By Christine Moore

Christine MooreFor over a decade, FDA has encouraged pharmaceutical manufacturers to use science- and risk-based approaches and to have strong pharmaceutical quality systems for the development and manufacture of drugs. These concepts were laid out in FDA’s 21st Century Initiatives back in 2004, and have further been elaborated on through FDA and international guidance, including ICH Q8(R2), Q9, Q10, and Q11. Experience has shown that a better understanding of the product and process, along with a robust pharmaceutical quality system, including formal risk management tools, can both enhance assurance of product quality and provide financial benefits to firms who utilize them. Continue reading

An Exciting Opportunity to Digest Biotechnology in San Diego


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By Prathap Shastri

Prathap ShastriWith an increasing interest in biologics, it is important to keep up with new innovations, emerging guidances, and advancements in the field of biotechnology. The U.S. biotechnology market has shown progressive growth dominating the global market: In 2012, it accounted for about 47% of the global biotechnology market. As the early biotech products near their patent expiration dates, biosimilars have gotten great attention throughout the industry and have led to a significant amount of investment in terms of time and research. More than 20 biosimilars are already approved in Europe and India, and the advent of biosimilars has already shown competitive pricing for the brand product. Continue reading

Is Poor Oral Bioavailability on Your Mind?


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By Jasmine Musakhanian

Jasmine Musakhanian-finalAs a pharmaceutical scientist, chances are, you have already looked into a number of enabling technologies that may help improve the delivery of that difficult drug candidate. In the process, you have surely come across some options: physical modification of the drug particles; salt formation or pro-drugs; complexation with cyclodextrins; crystal modifications; solid dispersions with polymers; and lipid based systems. The last is perhaps the hardest to pin, because it includes a host of drug delivery systems ranging from simplest oily solutions to lipid bilayers, self-micro-emulsifying drug delivery systems (SMEDDS) and solid SMEDDS to the more sophisticated nano-lipid carriers and complex colloidal or solid dispersions. Continue reading

Essential Regulatory Affairs for Pharmaceutical Scientists: A Live Session of Regulatory Affairs 101 eLearning Course


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By Monica Lee Whitmire

Monica Whitmire-finalStaying informed of regulatory affairs and staying abreast of the global regulatory landscape is critical to efficient and effective drug development and productive regulatory interactions, quality efficient submissions, and post-launch activities. Informed pharmaceutical scientists help present patients with various medicine options sooner rather than later. Pharmaceutical scientists who are able to proactively incorporate contemporaneous internationally relevant regulatory compliant study designs and appropriate statistical evaluation of data can greatly facilitate the project progression from early development, through GLP toxicology, safety and efficacy evaluations, first in human clinical studies, phase I, II, and III human clinical studies and successful market introduction. Continue reading

Cacophony to Harmony: Outcomes of the GBC Discussions on Science-based Bioanalytical Chromatographic Assays


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By Mark Arnold and Fabio Garofolo

Arnold-final2Fabio Garafolo-finalGrowth, transformation, transition, and diversification of bioanalytical science during the last ten years has led health authorities around the globe to develop regulations that contained a core of commonality, but also a variety of not-quite-the-same, to downright different requirements. As the noise level grew around how to respond to these regulations within the bioanalytical community, it became clear to both industry and regulators that harmonized best practices were needed. Thus, the Global Bioanalysis Consortium (GBC) was born “…as an all-inclusive consortium consisting of represented scientific associations with worldwide influence to merge existing or emerging bioanalytical guidance/guidelines to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.” Continue reading


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