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Blogs (2)
Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...
SCIENTIST SPOTLIGHT: Steven Froelich
Name: Steven Froelich
Blog: Formulating for Orphan Indication Drug Products
According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects...
Blog: Considerations for Abuse-Deterrent Category One Syringeability Studies
The use of opioid medications for pain management continues to increase, generating an inevitable...
Beyond the Bench: A Century of Experience
The second edition of the Beyond the Bench series features three of
Elevate Product Stewardship and Exceed Your Sustainability Goals
At Alcami, the health of our workers is not taken lightly. Rooted in the foundation of The Alcami...
Understanding Pharmaceutical Packaging
For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are...
Blog: Stability’s Role in the Drug Formulation Process
From molecule discovery through product release to market, quality attributes are carefully...
Abuse-Deterrent Studies – An Interview with Angela Moore
As one of the key contributors to current abuse-deterrent studies being performed in the Alcami...
Blog: The Impact of Stability Studies on APIs and Drug Products
Can you answer any of these questions?
Stability Testing of Quality Attributes for Drug Products
The quality attributes that everyone strives for are safety, product efficacy and integrity,...
Part Two: Cell-Based Bioassays
Part Two: Cell-Based Bioassays
Part One: Biologics and the Problem with Residual DNA
Part One: Biologics and the Problem with Residual DNA
In-Use Stability Testing: Providing the Right Instructions
In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active...
What are Extractables and Leachables?
Regulatory agencies have become increasingly rigorous with regards to the detection, identification...
Execution and Reporting of a Photostability Study Protocol
The protocol design, execution, and reporting of the confirmatory photostability for API and...
Bringing the Light to Photostability in Three Parts
Part 1: Basic Requirements – Setting the Stage
Antibiotic Potency Testing: Diffusion (Cylinder-Plate) Method
Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of...
Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics
Several agencies within the U.S. Federal government are focused on reducing the prescription drug...
Blog: The Effect of Abuse-Deterrent Formulations on Opioid Abuse
In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse...