Clinical Pharmacy Articles
Design and Optimization of NSAID Loaded Nanoparticles
The objective of the study was to design and evaluate NSAID loaded Nanoparticles drug delivery system,
where Flurbiprofen (model drug) Nanoparticles with suitable size range are envisaged to concentrate at
inflammation sites due to increase fragility of blood vessels at those sites and increased aggregation and
Clinical Investigations of Skeletal Fluorosis in Children of Manga Mandi in Pakistan
In July 2000 about 124 children were detected suffering from skeletal fluorosis at Manga
Mandi near Lahore. They were drinking high fluoride (maximum level 29 ppm)
containing water. We have studied various biochemical parameters in serum, including
alkaline phosphatase, calcium and inorganic phosphorus. These levels were compared
Evaluation of the rationality of some FDCs: Focus on antihypertensive drugs
The use of fixed-dose combinations is a widespread clinical practice in the treatment of various cardiovascular disorders. These fixed-dose combinations are valuable only when they have been developed based on sound rational pharmacokinetic and pharmacodynamic criteria, and when claims for their benefits have been supported by evidence-based data and well-designed clinical studies.
Effective Management of the Independent Imaging Review Process
The independent review of imaging and clinical data in oncology clinical trials is becoming increasingly important in supporting trial outcomes. The key to designing a successful independent review process centers on prospectively defining the methodology for the review.
Early in the development of an independent review process, several key documents are generated and signed off as agreements between a sponsor and imaging core lab. These documents include a project plan, Independent Review Charter, and the Investigator Site Manual.
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EU Approach to Safety: Vox Populi or Vox Dei?
In late February, the European Union announced it was launching a review of its rules on pharma-covigilance. It is not surprising that the EU should decide a review of pharmacovigilance is necessary. This is a constantly evolving discipline requiring constant alertness to how well it is meeting the objectives set for it.
What is surprising is the way that the EU chose to justify it in the formal announcement. In a statement entitled "Strengthening Medicines Safety Monitoring," it said: "A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening."
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The Clinical Side: Can we bridge the clinical-sales divide?
The medical science liaison position was created almost 40 years ago, and some of us may think our industry has progressed with the value proposition of this continually evolving role. However, considering the many challenges of cross-functional collaboration between medical science liaisons and other pharmaceutical functions, we have a long way to go toward building a collaborative environment where teamwork does not clash with compliance. The relationship between field sales forces and field MSL forces is a particularly touchy subject. In some cases, "joint calls," "gaining physician access" and "returns on investment" have become dirty words when used in the context of a sales representative-MSL relationship.
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The Clinical Side: Contribute to compliance
The rep's role in patient adherence
Jul 1, 2005
By: Jane Y. Chin
Pharmaceutical Representative
Former Surgeon General C. Everett Koop said it best: "Drugs don't work if people don't take them." Patient compliance, also known as patient adherence, is defined by the World Health Organization as "the extent to which a person's behavior -- taking medication, following a diet, and/or executing lifestyle changes -- corresponds with agreed recommendations from a healthcare provider." Noncompliance is a problem that crosses socioeconomic boundaries and can have serious consequences for patients.
The Clinical Side: The most important part of a study
On a short clinical call, a sales representative will have less than two minutes of clinical dialogue with the physician. This presents a challenging situation when a sales representative goes into a call with a predetermined clinical message. One may assume that short clinical calls are easier to prepare than that rare 15-minute appointment the representative may have with a doctor. The opposite is, in fact, true: The shorter the clinical call, the more science you need to know and the better-trained you must be at identifying exactly what you need to deliver and how you should deliver it.
The Clinical Side: The drug interactions maze
Many types of drug interactions can occur within the human body. Having a good working knowledge of this complex subject represents a huge opportunity for pharmaceutical representatives both to educate their customers and to better present their products.
A drug interaction can be defined as an increase or decrease in the available amount -- and therefore the effect -- of a medication caused by another medication, food or chemical that is simultaneously present in the body.
Sites of interaction
There are four main sites of interaction in the body.
The Clinical Side: Don't go DEAF on a call
The Clinical Side: Don't go DEAF on a call
Handling study objections Part 1
Oct 1, 2005
By: Jane Y. Chin
Pharmaceutical Representative
Trainers have told me that teaching sales representatives how to do a "clinical sell" remains their top priority. A critical part of teaching this is helping representatives communicate clinical data. In my last column, I suggested that on a short clinical call, representatives should cut the canned speeches, pick pertinent points and rank research results.
Representatives who execute these suggestions may soon be rewarded with a physician's objections to the clinical study they've presented. I say "reward" because when you engage physicians in a meaningful dialogue, an objection gives you more information on the factors they consider when making decisions than enthusiastic head-nodding (which may just mean they want you out of their office as soon as possible).
