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ArticlePedia - Appealing to the Reader
You’ve worked hard on your manuscript and are prepared to send it to a publisher. You realize your manuscript was not some According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product thing the publisher asked for specifically, yet you feel it matches their stated purpose. You have created a one page, con ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ise cover letter and have made sure it contains no spelling or grammar mistakes. The line is long at the post office, yet lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. you gladly wait to personally send the manuscript on its way. You watch as the heartless postal worker twists your packag here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe like a Frisbee into the ‘out’ bin. Quietly you walk back to the car and hope for the best. A week later the package you d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro repared is added to a rather significant pile of other manuscripts that have been sent to the same publisher with the same ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc belief that the work enclosed will make a solid addition to their line of book offerings. You wonder from time to time h easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi w things are going, but you don’t want to disturb the publisher. In the cold, callous world of publishing your manuscript nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically winds up in the ‘slush pile’ – a somewhat irritating pile of material publishers see every day just waiting to be read, b and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ t the publisher has little hope of actually finding something worth publishing from within that pile. The truth is the pu ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi lisher or editor may never actually look at your work. That’s not to say that your work is not reviewed. You see, most pub ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a lishers higher freelance ‘readers’ who will review the manuscript and weed out the ones that fail to meet the criteria of dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod he publisher. Most publishers are seeking a long-term relationship with a writer and they typically have very little need cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin for new talent. Instead of discouraging you, my hope is to instill the highest sense of professionalism in your work. Br tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen aking into publishing is hard work so resist the urge to simply throw something together and send it on with the belief yo t? As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel ’ve done what you could. The ‘reader’ will have to see something different from the others that will allow them to pass y ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust our manuscript on to an editor. What is that something? A one/two punch of professionalism and passion. Your story has to y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products be solid and meet their guidelines, but the ‘reader’ needs to detect that beyond a good manuscript you have a passion for . As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de your work and that you are professional enough to make the impression the editor is looking for. If done right, you not o elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ly impress the ‘reader’, but your manuscript may just get an audience with an editor while leaving the ‘slush pile’ behind tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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