Literature survey reveals that few analytical methods were reported for the estimation of cinacalcet hydrochloride by LC, UV methods. Hence the present study aims in developing simple, rapid, precise and validated methods for cinacalcet hydrochloride in bulk. The methods are Colorimetric determination of Cinacalcet Hydrochloride by Visible Spectrophotometric method, Validation of Cinacalcet Hyd...

Biotechnology pipelines have demonstrated significant growth over the past decade, with many therapeutic candidates evolving in a single class of protein molecules: the monoclonal antibodies (MAbs). To develop such therapeutic candidates, a scalable drug development process must leverage in-house and industry-wide knowledge so biotechnology companies can address the economic and medical needs o...

Method validation is an important requirement for any package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Analytical methods should be validated, including methods published in the relevant pharmacopoeia or other recognized standard references. The suitability of all test methods used should always be verifie...

A new transdermal delivery system that controls cellulitis is evaluated using reversed-phase high-performance liquid chromatography coupled with photodiode array detection. An extraction procedure and the validation of the analytical method to assay the active excipients from the Centella asiatica plant (asiaticoside, madacessic acid, and asiatic acid) are described. Excellent results ae obtain...

A strategy for reconciling the information requirements of formal measurement uncertainty estimation principles with data generated from classical analytical method validation studies is described in detail. The approach involves a detailed analysis of influence factors on the analytical results, employing cause and effect analysis, followed by a formal reconciliation stage. The methodology is ...

A recent publication includes a review of survival extrapolation methods used in technology appraisals of treatments for advanced cancers. The author of the article also noted shortcomings and inconsistencies in the analytical methods used in appraisals. He then proposed a survival model selection process algorithm to guide modelers' choice of projective models for use in future appraisals. Thi...