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Advice You - High Altitude Locomotives
When China decided to build a railroad line, which would be nearly 1 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 6,000 feet high a special locomotive had to be built to run at these ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in high altitudes, as well as oxygen had to be secured for those passe lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ngers and locomotive engineers. This technology had to be borrowed here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe from other sources and luckily there was a multinational corporation d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro which was able to handle this. General Electric has built the GE C 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 38AChe, which is a high altitude locomotive, which runs at optimum e 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 ven at high elevations. In fact, General Electric has built 78 of t nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically hese GE C38AChe Locomotives. Each one having 4000 hp and to they ar 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 e an engineering marvel of technology both old and new. If you look ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi t the GE C38AChe, you see that slightly resembles a locomotive, but ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a it's guts are state-of-the-art technology on the leading edge of loc dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod omotive engineering. Here's a picture; cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin //www.railpictures.net/viewphoto.php?id=133146" target="_blank">http tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ://www.railpictures.net/viewphoto.php?id=133146 The GE C38AChe 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 s able to operate over the Himalayas, something no other rail line h ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust as ever achieved and a bold step for trade indeed. Apparently, wheth y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products er it is building a Treasure Fleet, Great Wall, Massive Cities or ev . 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 en a railroad; China thinks big and boldly. Using the best technolog elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip y in the World, China is making the grade. Consider all this in 2006 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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