Pharmaceutical Technology-05-02-2013

BioForum
Pharmaceutical Technology

May 02, 2013

Applications of ZFN technology in biopharmaceutical cell-line engineering.

Pharmaceutical Technology
Statistical Solutions

May 02, 2013

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

Pharmaceutical Technology
Regulation & Compliance

May 02, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

Pharmaceutical Technology
Ask the Expert

May 02, 2013

James Stumpff, Principal Consultant at PAREXEL discusses supplier management and FDA's expectations.

Pharmaceutical Technology

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.

Pharmaceutical Technology
API Synthesis & Manufacturing

May 02, 2013

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.

Pharmaceutical Technology
Special Features

May 02, 2013

The impact of new delivery technologies in designing peptide therapies.

API Synthesis & Manufacturing
Pharmaceutical Technology

May 02, 2013

Solid-state chemistry is an important part of drug development, and public research is advancing the field.

Pharmaceutical Technology
Industry Leaders

May 02, 2013

A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends.

Industry Perspectives
Pharmaceutical Technology

May 02, 2013

New US patent rules change the playing field for open innovation.

Pharmaceutical Technology
Global Feature

May 02, 2013

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.

Pharmaceutical Technology

The author examines dry dispersion and outlines the related analytical method development.

Industry Perspectives
Pharmaceutical Technology

May 02, 2013

The author suggests co-opetition as a future model for collaboration in drug development.

Pharmaceutical Technology

Lyophilization technologies for controlled nucleation.

API Synthesis & Manufacturing
Pharmaceutical Technology

May 02, 2013

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.

Pharmaceutical Technology

New product reviews for May 2013, featuring automation, IT, and process control systems.

Regulation & Compliance
Pharmaceutical Technology

May 02, 2013

FDA faces budget crunch; Supreme Court hears key cases

Special Report
Pharmaceutical Technology

May 02, 2013

Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.

Pharmaceutical Technology
Cover Story

May 02, 2013

Optimized freeze-drying cycles can offer scientific and business advantages.

Pharmaceutical Technology

Loss-in-weight feeders provide high accuracy for batch or continuous processes.

Pharmaceutical Technology

Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.

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.

Pharmaceutical Technology
From The Editor

May 02, 2013

Wanted: Article contributions on drug and process development topics.

Issue PDF
Pharmaceutical Technology

May 02, 2013

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