RISK-BASED MONITORING – Making the Move to RBM: Improving Patient Safety & Data Quality With Real-Time Insights
Crystal Stone and Amanda Coogan indicate that in an era in which the time- and resource-intensive business model of developing blockbuster drugs has been supplanted by a push to move drug candidates through the pipeline with greater speed, accuracy, and quality, RBM and real-time data analytics are becoming a must-have for clinical trials.
Gregory A. Sacha, PhD, describes the devices used for process monitoring and how they can be used to detect end points during the process.
EXECUTIVE INTERVIEW – Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING – How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
STANDARD OPERATING PROCEDURES – How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
Martin Lehr, MA, says given the capital and intellectual capacity constraints within large pharmaceutical companies and start-ups, ISTs provide an important path to unlocking the therapeutic value of developmental and marketed drugs.
CONTAINER CLOSURE INTEGRITY – Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components
Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.
SPECIAL FEATURE – Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
IMAGE-BASED CHARACTERIZATION – Non-Invasive, Quantitative Characterization of Lyophilized Drug Product Using Three-Dimensional X-Ray Microscopy Analytics
Shawn Zhang, PhD, Johnathan Goldman, PhD, Xiaodong Chen, PhD, et al present a new method that not only characterizes quantitatively the microstructures of the lyophilized drug samples, but also presents the potential to correlate the microstructures with physical properties to optimize parameters in drug formulation, cycle development, process scale-up, stability control, and administration.
EXCLUSIVE ONLINE CONTENT
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