Pharmaceutical Technology, Feb 2, 2014 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Feb 2, 2014
Cover Story
More Rapid Extractable & Leachable Analyses with Advanced Mass Spectrometers
By Cynthia Challener, PhD
Advances in technology are improving the sensitivity and accuracy of mass spectrometry, increasing its use for the analysis of extractables and leachables.
Advanced triple quadrupole technology for improved performance and ease of use
By Cynthia Challener, PhD
Advanced triple quadrupole technology for improved performance and ease of use.
Simple and affordable mass detection for the chromatographer
By Cynthia Challener, PhD
Simple and affordable mass detection for the chromatographer.
Drug Delivery
Turkey Increases R&D Incentives
By Tugce Avc1sert Gecgil , Ozge At1lgan-Karakulak
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.
Featured Content
Pulmonary Drug Delivery—Particle Engineering for Inhaled Therapeutics
By Adeline Siew, PhD
Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.
Advances in UPLC Techniques and Column Chemistry Aid the Confirmation of Biosimilarity
By Cynthia Challener, PhD
Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.
Peer-Reviewed
Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLC
By N. Meera , S.D. Mankumare , K. Adyanth , T. Chakravarthy , K.R. Wadekar , P. Ravi
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).
API Synthesis & Manufacturing
Securing the Global API Supply Chain
By Cynthia Challener, PhD
Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.
Troubleshooting
Optimizing Warehouse Management
By Joe Scioscia
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.
Checklist for Computer Software Validation
By Henrik Johanning , John Lee , Christian Hemming , Lise Christensen
Non-compliance issues show that users find dealing with computer systems challenging.
Outsourcing Outlook
Novel Expression Systems Opening CMO Opportunities
By Eric Langer
CMOs may find opportunities in alternative expression services.
Regulatory Watch
FDA Focuses on Drug Appearance and Attributes
By Jill Wechsler
FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.
EMA Collaborates with HTA Assessment Networks
By Sean Milmo
High technology assessments are having an impact on biosimilars development in Europe.
Inside PDA
Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations
By Walter Morris
PDA works with FDA to create pharmaceutical quality metrics.
Global Feature
The Affordable Care Act's Impact on Innovation in Biopharma
By Jill E. Sackman, PhD , Rita E. Numerof, PhD , Michael Abrams
The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.
Ask the Expert
The Human Factor
By Siegfried Schmitt
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.
Editor's Comment
Defining Quality Metrics is No Easy Task
By Rita Peters
ISPE and PDA take on the challenge of recommending quality metrics.
Product Spotlight
FactoryTalk Software Increases Flexibility
By Melanie Sena
FactoryTalk Software Increases Flexibility
Software Expands Plant-Specific Analysis
By Melanie Sena
Software Expands Plant-Specific Analysis
Content Packages Accelerate MBR Creation
By Melanie Sena
Content Packages Accelerate MBR Creation

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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