Near infrared (NIR) spectroscopy was used for estimation of powder blend homogeneity and manufacturing control of a medicinal product powder mixture containing active pharmaceutical ingredient (API). Aiming at initiating a Process Analytical Technology (PAT) activity, the first step was a stationary mode at-line evaluation. In this, the content of pharmaceutical active compound in the powder mi...

Various marine habitats sustain variety of bio-sources of ecological and biotech potentials. Pharmaceutical potential compound Cyclosporine A was reported from marine fungus Microdochium nivale associated with Porteresia coarctata, a marine salt marsh grass from mangrove environment distributed along the Central West Coast (CWC) of India. This study involves association of M. nivale with P. coa...

The consensus statement by Unguru et al concerning national shortages of therapies used to treat children with cancer accomplishes 2 important tasks: it highlights a serious public health threat and proposes steps to address the problem. The working group (WG) has outlined 6 recommendations. All are constructive approaches and, in the case of the recommendations that are within US Food and Drug...

1.1. These guidelines apply to distribution of active substances, as defined in Article 1(3a) of Directive 2001/83/EC, for medicinal products for human use. According to that provision, an active substance is any substance or mix­ ture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product i...

Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. The method development and selection process remains subjective due to the po...

Informatics infrastructure plays a crucial role in supporting different decision making activities related to pharmaceutical product development, ilot plant and commercial scale manufacturing by streamlining information gathering, data integration, model development and managing all hese for easy and timely access and reuse. The foundation of such an infrastructure is the explicitly and formall...

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...

OBJECTIVES Restrictions on retail purchases of pseudoephedrine are one regulatory approach to reduce the social costs of methamphetamine production and use, but may impose costs on legitimate users of nasal decongestants. This is the first study to evaluate the costs of restricting access to medications on consumer welfare. Our objective was to measure the inconvenience cost consumers place on ...