Publication

Article

Pharmaceutical Technology

Pharmaceutical Technology-04-02-2003
Volume27
Issue 4

Identification of Out-of-Trend Stability Results

Author(s):

Mary Ann Gorko

Representatives from PhRMA member companies discuss the growing concern about out-of-trend stability data, including possible statistical approaches and the implementation challenges to identifying OOT results.

External Link - article-52982.pdf

Articles in this issue
Outsourcing Outlook
April 2003
Identification of Out-of-Trend Stability Results
The Relative Densisties of Pharmaceutical Powders, Blends, Dry Granulations, and Immediate-Release Tablets
Overhauling Compliance and GMPs
A Film Approach for the Stabilization of Gelatin Preparations Against Cross-Linking

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content
Kratom or Mitragyna speciosa on natural background. | Image Credit: © wasanajai - stock.adobe.com
August 1st 2025

FDA Seeks Scheduling Action to Control Harmful Kratom Plant Byproduct

Patrick Lavery
7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.
Drug Solutions Podcast: Sustainable Solutions for Biopharma
August 1st 2025

Drug Solutions Podcast: Sustainable Solutions for Biopharma

Patrick Lavery
In this podcast episode, we discuss sustainable approaches to such equipment and materials as medical propellants, flow sensor technology, and walk-in chambers, plus the critical role of women in elevating and accelerating development in these areas.
Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services. | Image Credit: © Tada Images - stock.adobe.com
August 1st 2025

3 Reasons FDA Says Quality Investments Are Essential for Drug Manufacturers and Patients

Patrick Lavery
FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
August 1st 2025

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

Patrick Lavery
In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
Glass vials for liquid samples. | Image Credit: ©nordroden - stock.adobe.com
August 1st 2025

Flexibility Provides Solutions to Small-Batch Manufacturing Challenges

Susan Haigney
Modular process design, single-use technologies, and flexible filling lines are some of the ways manufacturers can combat challenges involved in small-batch manufacturing.
woman face and hand with syringe making injection | Image Credit: © Syda Productions - stock.adobe.com
August 1st 2025

Boehringer Ingelheim, Re-Vana Therapeutics to Collaborate on Long-Acting Ophthalmic Therapies

Patrick Lavery
Re-Vana’s drug delivery technology is designed to release treatments over a 6- to 12-month period, with the goal of reducing frequency of injections for patients.