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Pharmaceutical Technology-04-02-2013
Pharmaceutical Technology
Strategic Partnering for Manufacturing
April 02, 2013
Outsourcing Outlook
37
4
Eisai and Biogen Idec pursue an innovative approach to capacity management.
Advancing Flow Chemistry in API Manufacturing
April 02, 2013
API Synthesis and Manufacturing
37
4
Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.
Report from Latin America
April 02, 2013
Global Feature
37
4
Latin America's diverse growing market seeks regulatory harmonization.
Fine-Chemical Producers Make Targeted Investments
April 02, 2013
Ingredients Insider
37
4
Contract API manufacturers proceed with select investment in capacity and service additions.
Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference Standards
April 02, 2013
Regulation & Compliance
37
4
This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.
Evaluating Equipment Utility and Innovation
April 02, 2013
Special Report
37
4
A Pharmaceutical Technology survey shows satisfaction with utility and innovation in most solid dosage and parenteral drug-manufacturing equipment.
Previewing Packaging Innovations
April 02, 2013
Packaging Forum
37
4
The annual INTERPHEX show presents end-to-end packaging solutions.
Process Analytical Technology and Process Control in Solid-Dosage Manufacturing
April 02, 2013
Cover Story
37
4
Industry is moving toward closed-loop control of continuous processing.
Method Validation by Design to Support Formulation Development
April 02, 2013
Peer-Reviewed Research
37
4
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
Bio/Pharmaceutical Facility Design and Operation: A Primer
April 02, 2013
Troubleshooting
37
4
A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training
Miniaturization of a Simulated Gastric Fluid Dispersion Experiment On a Microfluidics System
April 02, 2013
Peer-Reviewed Research
37
4
The miniaturization of preclinical safety assessment studies using a microfluidic chip system and optical microscopy can help reduce compound requirements, time, and costs in formulation development.
Ensuring Sterility of Parenteral Products
April 02, 2013
Manufacturing
37
4
Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.
Rounding Results for Comparison with Specification
April 02, 2013
Statistical Solutions
37
4
The mysteries of rounding are exposed; strict, unbiased rounding can be applied.
Report from Thailand
April 02, 2013
Global Feature
37
4
The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.
Report from Russia
April 02, 2013
Global Feature
37
4
Strengthening government control or striving for compliance with international standards?
The Affect of FDASIA on Inspections
April 02, 2013
Ask the Expert
37
4
David Elder, vice-president, technical at PAREXEL, discusses US legislation allows for inspection of generic-drug activities.
Moisture Permeation of Pharmaceutical Packaging
April 02, 2013
Inside USP
37
4
USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.
Manufacturers Under Pressure to Manage Painkillers
April 02, 2013
Regulatory Watch
37
4
Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.
The Need for Pharmacopeial Harmonization
April 02, 2013
Inside EDQM
37
4
In the context of international trade, the need to develop global quality standards for medicines is increasing.
Prescribing Caution for Biosimilars
April 02, 2013
Guest Editorial
37
4
Sound policies are needed to govern the substitution of interchangeable biologics.
Viral Vaccine Manufacturing
April 02, 2013
BioForum
37
4
A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.
INTERPHEX 2013: Aligning with Industry's Needs
April 02, 2013
Guest Editorial
37
4
Conference and exhibits provide a meeting place for professionals to exchange ideas.
Trends in GMP Violations
April 02, 2013
Regulation & Compliance
37
4
FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.
Regulatory Roundup
April 02, 2013
Regulation & Compliance
37
4
Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.
Advancing QbD in the EU
April 02, 2013
Regulatory Watch
37
4
The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
Pharmaceutical Technology, April 2013 Issue (PDF)
April 02, 2013
Issue PDF
37
4
Click the title above to open the Pharmaceutical Technology April 2013 issue in an interactive PDF format.