Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

FDA biosimilar guidance permits alternative drug delivery devices

“The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance… more ” According to Wikipedia… “Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s […]

A new roadmap for biopharmaceutical drug product development

“Quality by design (QbD) is a science- and risk-based approach to drug product development. Although pharmaceutical companies have historically used many of the same principles during development, this knowledge was not always formally captured or proactively submitted to regulators. In recent years, the US Food and Drug Administration has also recognized the need for more […]

BioWorld Today: Trial Subscription

Biotech’s Most Respected News Source For Over 18 Years FREE REPORT FREE 30-DAY Trial! No Obligation. No Credit Card Needed. To receive your FREE REPORT and FREE 30-DAY TRIAL to BioWorld Today, simply click here. Registration takes just 30 seconds and is FREE no credit card is required, and you’re under no obligation to buy […]

Dissolution Technologies in Elsevier Databases

Yesterday, I received an e-mail from Vivian Gray. Dissolution Technologies has been chosen for coverage in the Elsevier Bibliographic Databases. It will be included in their Abstract and Indexing service starting with the 2009 published material. As the worlds leading publisher of science and health information, Elsevier serves more than 30 million scientists, students, and […]

Dissolution Theory, Methodology, and Testing by Anthony Palmieri

I just got the latest copy of Dissolution Theory, Methodology, and Testing, by Anthony Palmieri! Vivian sent it to me, and asked me to review it. She knew I was all over Anthony to finish this book. Stayed tuned as peruse the pages… Hey Uncle Vince, would you mind if I wrote a review of […]

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