Additional Contributions:We thank Shu-Tuan Chiang, MSc, Chuang Song-Zong Pharmaceutical Co, Ltd, for the preparation of the studymedication and Hsiao-Jung Tseng, MS, Biostatistical Center for Clinical Research (supported by grant CLRPG340599 from Chang GungMemorial Hospital at Linkou) and Louis Tuan, MBA, Contract Research Organization Service Division, Formosa Biomedical Technology Corp, for s...

An asymmetrical FIA merging-zones manifold based on the dual injection of two sample microvolumes was developed for the simultaneous determination of salicylic acid and acetylsalicylic acid in pharmaceutical preparations at a sampling frequency of 30/h. The complex formed between the Fe(III) reagent continuously introduced in the system and salicylic acid was monitored photometrically at 520 nm...

For the PAT application of microbial monitoring instruments in pharmaceutical field, certain performance features of a detector technology are highly desirable, among them are: (1) real time microbial detection; (2) capability of continuous monitoring of microbial level in the environment; (3) broad detection range of microbes; (4) freedom from sample preparation and (5) ease of operation. To p...

Address for correspondence: Dr Vivekanandan Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Sector 23, Rajnagar, Ghaziabad, Uttar Pradesh 201002, India Email: [email protected] We wish to draw colleagues’ attention to the launch of a helpline facility for health-care professionals and the public – especially those in rura...

Natural products are structurally and biologically interesting metabolites, but they have been isolated in minute amounts. The syntheses of such natural products help in obtaining them in bulk amounts. The recognition of microbial biotransformation as important manufacturing tool has increased in chemical and pharmaceutical industries. In recent years, microbial transformation is increasing sig...

Lisa NisseN, B.Pharm., Ph.D., is Senior Lecturer, School of Pharmacy, The University of Queensland, St. Lucia, Queensland 4072, Australia ([email protected]). Dr. Nissen received an honorarium from the International Pharmaceutical Federation for preparing this article and acting as a working-group facilitator. Copyright © 2009, American Society of Health-System Pharmacists, Inc., and Internati...

one of the most significant issues in pharmaceutical industries, prior to commercializationof a pharmaceutical preparation is the “preformulation” stage. however, far too attention hasbeen paid to verification of the software assisted statistical designs in preformulation studies.the main aim of this study was to report a step by step preformulation approach for a semisolidpreparation based on ...

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necess...

Automated sample preparation enables highly reproducible quantitative analyses while meeting the increased efficiency needs often required for sample processing in laboratories. This application note describes results obtained using a liquid handling-based automation system for the sample preparation of compounds to be analyzed by LC-MS/ MS and applied to the monitoring of multiple classes of p...

Outsourcing is rapidly growing in the pharmaceutical industry. When the manufacturing activities are outsourced, control of the product's quality has to be maintained. One way to confirm contract manufacturer's GMP (Good Manufacturing Practice) compliance is auditing. Audits can be supported for instance by using GMP questionnaires. The objective of this study was to develop a tool for the audi...