General Articles

General

EC Questions Dual Pricing

Brussels, Belgium-Pfizer believes the dual pricing system it introduced in Spain complies with Spanish and European Union competition laws, but the European Commission isn't so sure. Competition policy commissioner Mario Monti says the EC will scrutinize Pfizer's pricing policy, which is intended to prevent parallel trade out of low-cost Spain. The investigation will initially determine whether the policy is similar to GlaxoSmithKline's practice of charging Spanish wholesalers more for medicines destined for export rather than for the home market. The commission ruled against GSK's policy earlier this year.

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Author(s): 
Kevin Gopal .
Journal: 
Pharmaceutical Executive, Dec 1, 2001.

Clinical Trial Packaging

Working for a clinical trial packaging contractor certainly has its rewards. If o­ne is fortunate enough, o­ne may witness a new chemical entity traverse the long, arduous climb from initial Phase I study all the way through NDA approval. Knowing that o­ne contributed in some small way brings satisfaction to the work. However, this work is not without its headaches. In particular, project planning and logistics are two beasts that, if not controlled properly, can wreak havoc with a production schedule and ultimately the bottom line of the business.

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Author(s): 
Joseph Saccomanno.
Journal: 
Contract Pharma April and May 2001.

International Union of Pharmacology. XV. Subtypes of -Aminobutyric AcidA Recepto

This article does not aim to review in detail the properties of -aminobutyric acidA (GABAA)b receptors, because recent accounts of that topic are available. In this same journal, a review of the binding properties and pharmacology of these receptors has been published (Sieghart, 1995). Other reviews have dealt with their ion channel properties as well as their pharmacology (MacDonald and Olsen, 1994; Mohler et al., 1996a,b), whereas others have concentrated o­n their molecular biology and protein structure (Wisden and Seeburg, 1992; Smith and Olsen, 1995; Stephenson, 1995; McKernan and Whiting, 1996). Further, two recent books have provided many short review articles o­n the functional, behavioral, and psychopharmacological aspects of GABA receptors (Tanaka and Bowery, 1996; Enna and Bowery, 1997) and an account of these latter aspects will not be repeated here.

Author(s): 
E. A. Barnard, P. Skolnick, R. W. Olsen, H. Mohler, W. Sieghart, G. Biggio, C. Braestrup, A. N. Bateson, and S. Z. Langer.
Journal: 
Pharmacol Rev 1998 50: 291-314.

The Cook Acquisition: Filling a Gap in Baxter’s Drug Delivery Business

Baxter International, Inc, is considered a global medical products and services company with a mission of delivering critical therapies for people with life-threatening conditions through its three major businesses - BioScience, Medication Delivery, and Renal. Its products and services are used to treat patients with many conditions, including cancer, trauma, hemophilia, immune deficiencies, infectious diseases, kidney disease, and other disorders.

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Author(s): 
Karen Blair.
Journal: 
Drug Delivery Technology, Vol 2 No 3 · May.

Monitoring Intracellular pH Changes in Response to Osmotic Stress and Membrane

Abstract

Intracellular free H+ concentration (pHi) responds to numerous extracellular stimuli. The use of fluorescent indicator dyes to measure pHi is strongly influenced by the ability of target cells to retain activated dye within the cytoplasmic compartment. Here, 3 pH-sensitive indicator dyes—acetoxymethyl (AM) esters of SNARF-1 and BCECF, and the thiol-reactive 5-chloromethyfluorescein (CMFDA)—were examined for monitoring pHi. The stability of pH measurements was strongly affected by temperature, cell type, indicator dye, and use of transport inhibitors to prevent dye export. Cellular retention of CMFDA, which forms covalent complexes, was sufficient to permit monitoring of transient pHi changes over extended time periods in a multi-well plate assay format. In human embryonic kidney (HEK293) and Chinese hamster ovary (CHO) cells, increasing osmotic pressure caused a significant rise in pHi.

Author(s): 
Aline Salvi, J. Mark Quillan, Wolfgang Sadée.
Journal: 
AAPS PharmSci. 2002; 4 (4): article 21.

Time- and Concentration-Dependent Penetration of Doxorubicin in Prostate Tumors

Abstract

The penetration of paclitaxel into multilayered solid tumors is time- and concentration-dependent, a result of the drug-induced apoptosis and changes in tissue composition. This study evaluates whether this tissue penetration property applies to other highly protein-bound drugs capable of inducing apoptosis. The penetration of doxorubicin was studied in histocultures of prostate xenograft tumors and tumor specimens obtained from patients who underwent radical prostatectomy. The kinetics of drug uptake and efflux in whole tumor histocultures were studied by analyzing the average tumor drug concentration using high-pressure liquid chromatography. Spatial drug distribution in tumors and the drug concentration gradient across the tumors were studied using fluorescence microscopy. The results indicate that drug penetration was limited to the periphery for 12 hours in patient tumors and to 24 hours in the more densely packed xenograft tumors.

Author(s): 
Jenny H. Zheng, Chiung-Tong Chen, Jessie L.-S. Au, M. Guill Wientjes.
Journal: 
AAPS PharmSci. 2001; 3 (2): article 15.

CRM Checklist for Success

Customer relationship management (CRM) has become a pharma buzzword, but few companies actually practice it. That is about to change. A new study by Braun Consulting, based o­n its work with Fortune 500 clients, identifies 11 trends that will affect the industry in 2002: Successful companies will invest more in customers, not less. Within the past 18 months, the economy has taken a nose dive from exuberance to retrenchment, forcing companies to closely examine their CRM investments and IT expenditures. Successful corporations will continue to invest in CRM initiatives, but they will shift their efforts from customer acquisition to customer retention. They will try to maximize the value of existing relationships and use customer information to both expand those relationships and extend their brands to other marketplaces.

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Author(s): 
Jim Kalustian , Bart Lombardi , Web Fletcher .
Journal: 
Pharmaceutical Executive, Feb 1, 2002 .

Policy: Task Masters

London-Government and industry have agreed there should be no weakening of patent protection in the effort to speed access to medicines in the developing world.Following a year-long competitiveness study, a joint government–industry task force concluded that intellectual property protection is not in itself a barrier to access and that weakening it would be counterproductive.

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Author(s): 
Kevin Gopal .
Journal: 
Pharmaceutical Executive, May 1, 2001 .

Headspace Liquid Microextraction

Derrick C. Wood, James M. Miller and Ingo Christ
LCGC Europe, Nov 1, 2004

Adding Value to the Products' Life-Cycle Management: Product Enhancement Through

Faced with soaring R&D costs, an impending o­nslaught of patent expirations, mega-merger mania, and increasing consumer demands for improved medications, pharmaceutical companies are relying more heavily o­n advanced drug delivery technologies to help sustain the high growth and profit margins they have been experiencing since the 90s. With more than 50 patents expiring by 2005, including a number of blockbuster drugs, they are under intense pressure to replace these losses with new or improved drugs.


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Author(s): 
Anand Baichwal, and Deborah A. Neville.
Journal: 
Drug Delivery Technology, Volume1 No.1 · October 2001.
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