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November 18, 2019
This application note covers HRAM multi-attribute method for critical quality attribute monitoring and new peak detection, including optimization and application.
November 11, 2019
October 29, 2019
This article reviews the dangers of endotoxins and the importance of choosing low endotoxin products for product contact areas.
October 28, 2019
In this executive summary, experts will present the in vitro dissolution and an in vivo bioequivalence study comparing the performance of the identical formulation of three different drugs in Capsugel® Vcaps® Plus capsules to hard gelatin capsules. In addition, the circumstances under which the same API and formulation contained in HGC and Capsugel® Vcaps® Plus can be expected to provide equivalent performance will be discussed.
The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade, from 10 percent to 27 percent.
The challenges for new drugs looking to enter the market are numerous. But many are self-inflicted – especially in small molecule development. A dangerous perception persists that aside from highly potent APIs, small molecule medications have simple process requirements. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
October 24, 2019
• How to balance compliance needs with creating useful SOPs. • Tips and tricks for ensuring consistency. • Why and how you should test your SOPs
from A technical review of compounding, devolatilization, reactive processing, foaming and direct extrusion via twin screw extruders
October 23, 2019
Learn how regulators define temporary data and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.
Detecting the presence and depth of penetration of drug compounds in skin can prove challenging, current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw Biological Analyser - RA816 confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.