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Pharmaceutical Technology-05-02-2013
Pharmaceutical Technology
ZFN Technology Advances Biopharmaceutical Manufacturing
May 02, 2013
BioForum
37
5
Applications of ZFN technology in biopharmaceutical cell-line engineering.
Compositing Samples and the Risk to Product Quality
May 02, 2013
Statistical Solutions
37
5
Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.
Regulatory Convergence Sought for Global Pharma Market
May 02, 2013
Regulation & Compliance
37
5
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
FDA Expectations for Supplier Management
May 02, 2013
Ask the Expert
37
5
James Stumpff, Principal Consultant at PAREXEL discusses supplier management and FDA's expectations.
Should Regulation of Combination Products Become More Centralized in Europe?
May 02, 2013
Regulation & Compliance
37
5
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
Intellectual Property Battles in Solid-State Chemistry
May 02, 2013
API Synthesis & Manufacturing
37
5
The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.
Prefilled Syringes or Peptide Pills?
May 02, 2013
Special Features
37
5
The impact of new delivery technologies in designing peptide therapies.
Academic and Public Partnerships in Solid-State Chemistry
May 02, 2013
API Synthesis & Manufacturing
37
5
Solid-state chemistry is an important part of drug development, and public research is advancing the field.
Q&A with Stuart E. Needleman, Aptuit
May 02, 2013
Industry Leaders
37
5
A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends.
New First-to-File Patent Rule Threatens Open Collaboration
May 02, 2013
Industry Perspectives
37
5
New US patent rules change the playing field for open innovation.
Report from Brazil May 2013
May 02, 2013
Global Feature
37
5
Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.
Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis
May 02, 2013
Peer-Reviewed Research
37
5
The author examines dry dispersion and outlines the related analytical method development.
Co-Opetition in Drug Development
May 02, 2013
Industry Perspectives
37
5
The author suggests co-opetition as a future model for collaboration in drug development.
Controlling Ice Nucleation During the Freezing Step of Lyophilization
May 02, 2013
Cover Story
37
5
Lyophilization technologies for controlled nucleation.
Using Thermal Ink-Jet Printing Technology to Produce Pharmaceutical Cocrystals
May 02, 2013
API Synthesis & Manufacturing
37
5
Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.
Product Spotlight: Automation/IT/Process Control
May 02, 2013
In the Spotlight
37
5
New product reviews for May 2013, featuring automation, IT, and process control systems.
Regulatory Roundup
May 02, 2013
Regulation & Compliance
37
5
FDA faces budget crunch; Supreme Court hears key cases
Facility Trends: Modularization and Single Use
May 02, 2013
Special Report
37
5
Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.
Lyophilization: A Primer
May 02, 2013
Cover Story
37
5
Optimized freeze-drying cycles can offer scientific and business advantages.
Using a Gravimetric Feeder to Dose Pharmaceutical Bulk Solids
May 02, 2013
Troubleshooting
37
5
Loss-in-weight feeders provide high accuracy for batch or continuous processes.
Outsourcing's Modest Role as a Cost-Containment Strategy
May 02, 2013
Outsourcing Outlook
37
5
Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances
May 02, 2013
Peer-Reviewed Research
37
5
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
Pathway to Publication
May 02, 2013
From The Editor
37
5
Wanted: Article contributions on drug and process development topics.
Pharmaceutical Technology, May 2013 Issue (PDF)
May 02, 2013
Issue PDF
37
5
Click the title above to open the Pharmaceutical Technology May 2013 issue in an interactive PDF format.