April/May/June 2023

Volume 24, Issue 2

Browse other issues »Subscribe to our print issues »

Articles in this Issue

What Is Extreme Quality Manufacturing and Why Is It So Important?

CC Wellness is a small company in the heart of the Santa Clarita Valley in southern California. The company manufactures personal lubricants, over-the-counter (OTC) drug products, and cosmetics, and has fully embraced a world-... read more
How to De-Risk Clinical Trials in Today’s Complex Environment

Halfway through 2023, the clinical trials space has never been more exciting, and turbulent. There have been some incredible breakthroughs, such as the success of Enhertu, an experimental drug used in a clinical trial sponsored by... read more
Science and Tech Innovation Drive Promise of Therapeutic Cancer Vaccines

Cancer research has come a long way in a short space of time. As immunotherapy and gene therapy pioneer Dr. Stephen Rosenberg has pointed out, the traditional tools available to treat cancer - surgery, chemotherapy and ... read more
A Reliable Method for Quantitating Extractables and Leachables in Medical and Pharmaceutical-Grade...

Extractable and leachable (E&L) assessments and testing are part of a key regulatory requirement for many types of pharmaceutical products and food packaging systems to ensure product integrity and patient safety. E&L compounds ... read more
No API Without Excipients? How to Use Business Strategy and Forecasting to Ensure Supply and...

Just like a hand is to a glove, excipients are to pharmaceutical APIs. Any drug formulation is composed of two components or aspects. According to a MarketsandMarkets research report, the global pharmaceutical excipients market ... read more
Benchtop Blast Freezers Simplify R&D of Temp Sensitive Materials

Pharmaceutical manufacturers often require cryogenic blast freezers that can rapidly freeze and subsequently thaw thermally sensitive materials in the R&D phase for new drugs, vaccines, and biological products. It is important to ... read more
The Importance of Maximum Tolerated Dose (MTD) Testing in Preclinical Studies

According to the U.S. FDA, a drug's maximum tolerated dose (MTD) is the "highest dose that does not produce unacceptable toxicity." But the toxicity level considered "unacceptable" can be a relative term. Some level of toxicity ... read more
A Quarterly Review of New Drug Applications – January-March 2023

This quarterly review of New Drug Applications contains data for applications approved during the first quarter of 2023, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 applications were approved by ... read more
Editor's Message: Bank Robbers, Boats, and the Basics

“I rob banks because that’s where the money is.” Sometimes quotes like these take on a life of their own. Attributed to the bank robber Willie Sutton, Sutton during his life claims he never said it. According to the Snopes.com ... read more