Wednesday, March 25, 2015
Lipinski’s seminal paper on experimental and computational (in silico) methods to estimate the solubility and permeability of drug candidates
was published in 1997. The iconic “Rule of 5” predicted that absorption was adversely impacted when the ...
Wednesday, August 07, 2013
Analytical method transfers are an integral part of the product
lifecycle of medicinal products, particularly as they are moved
between different sites (often not within the same company, i.e.,
outsourcing). There is a requirement under current ...
This third article in a series on genotoxic/mutagenic impurities (GTIs)
will discuss the challenges facing synthetic and analytical chemists
as they endeavor to identify and ultimately control levels of these
GTIs or PGIs (potentially genotoxic ...
Sunday, September 16, 2012
This second article on genotoxic / mutagenic impurities (GTIs) will focus on toxicological aspects and discuss in more detail some of the themes mentioned in the first part of the series [1]. The current [2,3] and evolving guidance [4] is based on a ...
This series of articles is intended to provide a general overview of the issues surrounding genotoxic impurities (GTIs) and their potential resolution. Part 1 will focus on general and regulatory aspects, part 2 will review toxicological issues, ...
One of the least desired outcomes of utilizing combinatorial and
high throughput chemistry has been a marked increase in poorly
soluble drug candidates.