A two-step computational method for designing new molecules in medicinal chemistry is described. In the first step, topological indices are used to develop structure-based correlations for properties of interest. Zeroth and first order connectivity indices are employed to develop linear correlations for three physical properties of interest in pharmaceutical chemistry: octanol–water partition c...

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study. hotostability testing in the pharmaceutical industry has evolved rapidly, particularly since the May 1997 publication of the ICH Q1B guidance “...

Development of a pharmaceutical product involves several inter-related steps with multiple decisions requiring iterative improvements. Large amounts of information, including the properties of a drug substance, interactions of materials, unit operations, equipment etc, have to be gathered and used for decision making. A systematic model of the associated information is thus needed to streamline...

10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfa...

The pharmaceutical industry relies on innovation. However, many innovative firms are cutting their research and development investments and seeing their new product pipelines dry up, due in part to a lack of sufficient patent protection. This Note identifies two major factors that have caused this inadequacy in patent protection. First, pharmaceutical patents are challenged early and often by g...

Developing a pharmaceutical product has become increasingly difficult and expensive. With an emphasis on developing project knowledge at an earlier stage in development, the use of information-rich technologies (particularly MS) has continued to expand throughout product development. Continued improvements in LC/MS technology have widened the scope of utilizing MS methods for performing both qu...