Analytics

Jan 01, 2003
Pharmaceutical Technology Europe
It has been demonstrated that the existing FDA dose content uniformity test has very poor statistical relevance, which has resulted in the acceptance of poor quality batches and the rejection of good quality batches. By using Bayesian Inference, a much improved test has been produced that allows the quality of a batch of drug product to be determined accurately, using a suitable number of samples for the quality of the batch.
Jan 01, 2003
Pharmaceutical Technology Europe
By Albedo
Brussels report
Dec 01, 2002
Pharmaceutical Technology Europe
Spectroscopy using light is a familiar technique and the electromagnetic spectrum from UV to IR is routinely employed. This article looks at the advantages and applications of spectroscopy using sound waves, with special reference to pharmaceutical research.
Nov 01, 2002
Pharmaceutical Technology Europe
Dry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.
Nov 01, 2002
Pharmaceutical Technology
By Pharmaceutical Technology Editors
An all-electronic validation can provide storage costs savings and ensured document legibility.
Oct 01, 2002
Pharmaceutical Technology Europe
A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
Oct 01, 2002
Pharmaceutical Technology Europe
Using melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.
Sep 02, 2002
Pharmaceutical Technology
The author discusses the potential effect on CROs of pending major-pharma mergers and consolidations.
Aug 01, 2002
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The author explains how a sponsor company can select and partner with a CRO for the redevelopment and revalidation of analytical test methods.
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