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Pharmaceutical Technology-10-02-2018
Pharmaceutical Technology
Drug Delivery Innovation Funded by the Gates Foundation
October 02, 2018
Features
42
10
The Global Health division of the Bill and Melinda Gates Foundation is seeking solutions for health problems, such as infectious diseases, that impact the developing world, including identifying drug delivery forms to compensate for a lack of infrastructure in these regions.
New Dose Forms Focus on the Patient
October 02, 2018
Cover Story
42
10
Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.
Protecting Solid-Dose Shelf Life
October 02, 2018
Features
42
10
Barrier materials, scavengers, and good seal integrity maximize shelf-life of oral solid-dosage drug packaging.
Considering Twin-Screw Granulation
October 02, 2018
Features
42
10
A twin-screw extruder can be used as a continuous wet granulator.
Optimizing Containment in OSD Manufacturing
October 02, 2018
Features
42
10
Engineering controls and safe practices for containment protect both operator and product in tablet and capsule production.
Sartan Recalls Beg the Question: Is Compendial Impurity Testing Enough?
October 02, 2018
Features
42
10
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Developing Lipid-Based Formulations
October 02, 2018
Features
42
10
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
Efficiency Demands Drive Advances in API Labs
October 02, 2018
API Synthesis and Manufacturing
42
10
Integration of new modeling and analytical tools with flow chemistry are notable trends.
AAPS Traces the Path to ICH M10
October 02, 2018
Guest Editorial
42
10
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
Outsourcing Development: Small-Scale to Commercial
October 02, 2018
Features
42
10
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
The Link Between Data Integrity and Quality Culture
October 02, 2018
Ask the Expert
42
10
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Curbing Drug Shortages in Europe
October 02, 2018
Regulatory Watch
42
10
A European task force outlines its upcoming efforts to combat drug shortages.
Process Stability, Performance, and Capability; What is the Difference?
October 02, 2018
Statistical Solutions
42
10
This article applies the basics of stability, performance, and capability to modern process performance and capability indices.
Lot Release Testing Analytics for Small-Molecule Drugs
October 02, 2018
Features
42
10
Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.
Pharmaceutical Technology North America, October 2018 (PDF)
October 02, 2018
Issue PDF
42
10
Click to view Pharmaceutical Technology North America, October 2018 (PDF).
Understanding Internal Release Limits
October 02, 2018
Peer-Reviewed Research
42
10
Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
Using Nondestructive in-situ Measurements to Ensure Lyophilized Product Stability
October 02, 2018
Features
42
10
Non-destructive surface area measurement can improve stability testing.
Hygienic Connection Box Range
October 02, 2018
Product Spotlight
42
10
Flexicon’s new range of stainless steel connection boxes are suited for applications requiring high levels of hygiene and ingress protection.
Low-Profile, Sanitary Screener
October 02, 2018
Product Spotlight
42
10
A new Low-Profile, Flo-Thru Sanitary Screener from Kason scalps oversize particles and foreign matter from dry bulk materials and solids-laden slurries at high rates in low headroom areas.
Custom Multi-Shaft Mixer
October 02, 2018
Product Spotlight
42
10
Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.
Mass Spectrometer for Analyzing Complex Samples
October 02, 2018
Product Spotlight
42
10
The LCMS-9030 quadrupole time-of-flight (TOF) liquid chromatograph mass spectrometer from Shimadzu is a researchgrade mass spectrometer suited to deliver high-resolution, accurate-mass detection with fast data acquisition rates.
FDA Clarifies Worldwide Inspection Policies
September 12, 2018
Regulatory Watch
42
10
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.