Pharmaceutical Technology-04-02-2013

Pharmaceutical Technology
Outsourcing Outlook

April 02, 2013

Eisai and Biogen Idec pursue an innovative approach to capacity management.

Pharmaceutical Technology
API Synthesis and Manufacturing

April 02, 2013

Continuous flow chemistry offers potential for greater control, improved safety and environmental profiles, and efficient chemical transformations.

Pharmaceutical Technology
Global Feature

April 02, 2013

Latin America's diverse growing market seeks regulatory harmonization.

Ingredients Insider
Pharmaceutical Technology

April 02, 2013

Contract API manufacturers proceed with select investment in capacity and service additions.

Pharmaceutical Technology

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.

Pharmaceutical Technology
Special Report

April 02, 2013

A Pharmaceutical Technology survey shows satisfaction with utility and innovation in most solid dosage and parenteral drug-manufacturing equipment.

Pharmaceutical Technology
Packaging Forum

April 02, 2013

The annual INTERPHEX show presents end-to-end packaging solutions.

Industry is moving toward closed-loop control of continuous processing.

Pharmaceutical Technology

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.

Pharmaceutical Technology

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

Pharmaceutical Technology

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.

Pharmaceutical Technology
Manufacturing

April 02, 2013

Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Statistical Solutions

April 02, 2013

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Pharmaceutical Technology
Global Feature

April 02, 2013

The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.

Global Feature
Pharmaceutical Technology

April 02, 2013

Strengthening government control or striving for compliance with international standards?

Pharmaceutical Technology
Ask the Expert

April 02, 2013

David Elder, vice-president, technical at PAREXEL, discusses US legislation allows for inspection of generic-drug activities.

Inside USP
Pharmaceutical Technology

April 02, 2013

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

Pharmaceutical Technology

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

Pharmaceutical Technology

In the context of international trade, the need to develop global quality standards for medicines is increasing.

Pharmaceutical Technology
Guest Editorial

April 02, 2013

Sound policies are needed to govern the substitution of interchangeable biologics.

BioForum
Pharmaceutical Technology

April 02, 2013

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

Pharmaceutical Technology

Conference and exhibits provide a meeting place for professionals to exchange ideas.

Regulation & Compliance
Pharmaceutical Technology

April 02, 2013

FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.

Regulation & Compliance
Pharmaceutical Technology

April 02, 2013

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

Pharmaceutical Technology
Regulatory Watch

April 02, 2013

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

Issue PDF
Pharmaceutical Technology

April 02, 2013

Click the title above to open the Pharmaceutical Technology April 2013 issue in an interactive PDF format.