Pharmaceutical Technology-08-01-2009

Pharmaceutical Technology

Outsourcing Stability Studies

August 01, 2009

Articles

2009 Supplement

43

The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies.

Issue Extra: Executive Roundtable—The Future of Pharmaceutical CMC Outsourcing

August 01, 2009

Online Exclusives

2009 Supplement

43

A Q&A with Pfizer CentreSource, moderated by Jim Miller.

Waivers and Deferrals Under the Pediatric Research Equity Act

August 01, 2009

Online Exclusives

2009 Supplement

43

The authors explain waivers and deferrals for pediatric studies of drugs and biologics as provided by the Pediatric Research Equity Act of 2007.

European Requirements for Pediatric Formulations

August 01, 2009

Online Exclusives

2009 Supplement

43

A summary of recent changes to European regulatory requirements for pediatric formulations.

Pediatric Formulations: Technical and Regulatory Considerations

August 01, 2009

Articles

2009 Supplement

43

Leading experts share their perspective on the specialized requirments when developing a pediatric formulation and examine dosage forms that can be used for this patient class in this roundtable moderated by Patricia Van Arnum.