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Pharmaceutical Technology-05-02-2017
Pharmaceutical Technology
The Complexity of IDMP
May 08, 2017
Regulatory Watch
41
5
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
Transforming Regulatory Data Management
May 08, 2017
41
5
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
Optimizing Yields on Modern Tablet Presses
May 02, 2017
Troubleshooting
41
5
Learn how to prevent common causes of product loss.
Robots Package Parenteral Products
May 02, 2017
Packaging Forum
41
5
Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.
Combination Products Raise New Manufacturing Challenges
May 02, 2017
Regulatory Watch
41
5
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Engaging with Interest Groups or Industry Associations
May 02, 2017
Ask the Expert
41
5
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
CMOs and CROs Have Different Trajectories
May 02, 2017
Outsourcing Outlook
41
5
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
Catalysis, Flow Chemistry Impact API Manufacturing
May 02, 2017
API Synthesis and Manufacturing
41
5
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
Keeping an Eye on Quality
May 02, 2017
From The Editor
41
5
New study will reveal bio/pharma practices and performance on quality issues.
MACRA and Value-Based Contracts
May 02, 2017
Cover Story
41
5
Under US regulations, such as the Medicare Access and CHP Reauthorization Act of 2015 (MACRA), part of any US physician’s reimbursement will be based on patient outcomes.
Innovating in a Value-Based World
May 02, 2017
Cover Story
41
5
Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.
Impact of PFS and Filling Process Selection on Biologic Product Stability
May 02, 2017
Features
41
5
The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.
Alternative Routes for Delivering Macromolecules
May 02, 2017
Formulation
41
5
Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.
Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable Studies
May 02, 2017
Features
41
5
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation
May 02, 2017
Peer Reviewed
41
5
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
Sanitary Lab Mixer
May 02, 2017
Product Spotlight
41
5
The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.
Portable Conveyor for Transporting Bulk Materials
May 02, 2017
Product Spotlight
41
5
The portable Flexible Screw Conveyor from Flexicon can be tilted and rolled to serve multiple functions.
USB Data Logger
May 02, 2017
Product Spotlight
41
5
The LogTag UTRID-16 Data Logger System from CiK Solutions GmbH includes a built-in USB connector, automatic PDF report generation, and six-level multi-alarm display.
Custom Built ASME Tanks
May 02, 2017
Product Spotlight
41
5
Ross Engineering’s ASME tanks are custom built to serve a wide range of applications and processing requirements.
Pharmaceutical Technology, May 2017 Issue (PDF)
May 02, 2017
Issue PDF
41
5
Click the title above to open the Pharmaceutical Technology May 2017 issue in an interactive PDF format.