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Pharmaceutical Technology-02-02-2021
Pharmaceutical Technology
Drug Developers Put Pedal to the Metal
February 03, 2021
Cover Story
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New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?
The Value of Pharmacopeial Reference Standards
February 03, 2021
Peer-Reviewed Research
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This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.
Exploring the Therapeutic Value of Blood Components
February 03, 2021
Development
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Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.
Developments Driving Drug Delivery
February 03, 2021
Development
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Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.
Reshoring Pharmaceutical Manufacturing to the US: Can We Do It?
February 03, 2021
Manufacturing
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Advanced manufacturing technologies are available, but challenges need to be addressed.
Optimizing Tech Transfer with Advanced Analytics
February 03, 2021
Manufacturing
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Sharing process insights across the stages of drug development improves tech transfer.
Understanding Concomitant Components in Pharmaceutical Excipients
February 03, 2021
Quality/Regulations
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Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.
Approaching Elemental Impurity Analysis
February 02, 2021
Analytics
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Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.
Countering Counterfeiters and Diverters
February 02, 2021
Operations
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Anticounterfeiting technology protects the supply chain from manufacturer to patient.
Toxicology: Ensuring Drugs are Safe for People
February 02, 2021
Outsourcing
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Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
Continued Innovation is Key for COVID-19 Recovery
February 02, 2021
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More work is needed to educate businesses on the value of innovation and the availability of funding.
FDA Inspection Shutdown Increasingly Delays Approvals
February 02, 2021
Regulatory Watch
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FDA puts applications on hold as the agency limits alternative oversight methods.
Getting Tough on Supplies
February 02, 2021
Regulatory Watch
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The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.
In Short Supply
February 02, 2021
From The Editor
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COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.
How Pharmaceutical Innovation is Saving the World
February 02, 2021
From The Editor
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Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.
Frequently Asked Questions on Regulatory Inspections
February 02, 2021
Ask the Expert
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Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.
A Hopeful but Dangerous Phase
February 02, 2021
From The Editor
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A complicated vaccination rollout and mixed messages may derail the pandemic endgame.
Compact Granulation Line
February 02, 2021
Product Spotlight
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Romaco Innojet’s IGL 100 granulation line is intended for production-scale processing applications and combines high-shear mixing and granulation, fluid bed drying, fluid bed granulation, fluid bed pellet coating, and fluid bed hot melt coating into one unit.
Liquid Chromatographs for Remote Work
February 02, 2021
Product Spotlight
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Advanced i-Series liquid chromatographs from Shimadzu provide users with the ability to analyze a large number of samples and re-process data while working remotely.
Robotic Modular System for Small Batch Filling
February 02, 2021
Product Spotlight
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The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.
Dual-Shaft Mixer with High Shear Rotor/Stator
February 02, 2021
Product Spotlight
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ROSS incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements.