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Pharmaceutical Technology-02-02-2014
Pharmaceutical Technology
FDA Focuses on Drug Appearance and Attributes
February 02, 2014
Regulatory Watch
38
2
FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.
Turkey Increases R&D Incentives
February 02, 2014
Drug Delivery
38
2
Last year, the Turkish Government unveiled plans to position the country in the top 10 most-preferred locations for R&D investment in the pharmaceutical sector by 2023. This article provides an overview of the incentives introduced under the Technopolis Law and the R&D Act.
EMA Collaborates with HTA Assessment Networks
February 02, 2014
Regulatory Watch
38
2
High technology assessments are having an impact on biosimilars development in Europe.
Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
February 02, 2014
Inside PDA
38
2
PDA works with FDA to create pharmaceutical quality metrics.
Novel Expression Systems Opening CMO Opportunities
February 02, 2014
Outsourcing Outlook
38
2
CMOs may find opportunities in alternative expression services.
Pulmonary Drug Delivery—Particle Engineering for Inhaled Therapeutics
February 02, 2014
Featured Content
38
2
Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.
Defining Quality Metrics is No Easy Task
February 02, 2014
38
2
ISPE and PDA take on the challenge of recommending quality metrics.
More Rapid Extractable & Leachable Analyses with Advanced Mass Spectrometers
February 02, 2014
Cover Story
38
2
Advances in technology are improving the sensitivity and accuracy of mass spectrometry, increasing its use for the analysis of extractables and leachables.
Content Packages Accelerate MBR Creation
February 02, 2014
Product Spotlight
38
2
Content Packages Accelerate MBR Creation
Advanced triple quadrupole technology for improved performance and ease of use
February 02, 2014
Cover Story
38
2
Advanced triple quadrupole technology for improved performance and ease of use.
The Human Factor
February 02, 2014
Ask the Expert
38
2
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.
The Affordable Care Act's Impact on Innovation in Biopharma
February 02, 2014
Global Feature
38
2
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity
February 02, 2014
Featured Content
38
2
Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.
FactoryTalk Software Increases Flexibility
February 02, 2014
Product Spotlight
38
2
FactoryTalk Software Increases Flexibility
Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLC
February 02, 2014
Peer-Reviewed
38
2
The authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
Simple and affordable mass detection for the chromatographer
February 02, 2014
Cover Story
38
2
Simple and affordable mass detection for the chromatographer.
Work-in-Process Tracking Software
February 02, 2014
Product Spotlight
38
2
Work-in-Process Tracking Software
Software Expands Plant-Specific Analysis
February 02, 2014
Product Spotlight
38
2
Software Expands Plant-Specific Analysis
Checklist for Computer Software Validation
February 02, 2014
Troubleshooting
38
2
Non-compliance issues show that users find dealing with computer systems challenging.
Optimizing Warehouse Management
February 02, 2014
Troubleshooting
38
2
Although software and the overall warehouse management solution (WMS) are crucial tools, common problems include failure to put in place an efficient warehouse layout best suited to the products being handled, lack of knowledge of the inventory on hand, and inadequate preparation and training of personnel.
Securing the Global API Supply Chain
February 02, 2014
API Synthesis & Manufacturing
38
2
Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.
Pharmaceutical Technology, February 2014 Issue (PDF)
February 02, 2014
Issue PDF
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Click the title above to open the Pharmaceutical Technology February 2014 issue in an interactive PDF format.