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E-Articles - Know Your Man: Being A Sum of Parts
"I'm a human being all the time, even when I sleep. But I'm not a musician when I sleep, and I'm not a m 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 usician when I eat, unless I'm paying attention to music or talking about music." ~ Herbie Hancock We n ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in eed to understand that, unlike us, a man is a sum of his parts; it is the components that make the whole lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. . By that I mean that, all the various parts of his life can be split off from each other, just like a b here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ook shelf: work in one shelf, relationships in another shelf, barbecuing in another shelf, sports in a f d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ourth shelf, parenting in another, and so on. That means that depending on what activity he is involved 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 in, he will not pay attention to us. We must remember this or we will suffer. I was once in this frame, 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 absolutely in love with this man. Like me, he was a professor and one day, I entered in one of his clas nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ses, hoping he would pay attention to me, or send me looks of love, or say something... what was I think 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 ing? Well, when the surprise of seeing me wore off "took him 5 seconds" he continued his lesson as usual ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ignoring me entirely, as if I was not even there. I felt really bad thinking that he was angry at me a ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a nd asking what had I done to deserve such treatment, and so and so forth. Stupid me; he was just being h dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod imself. And guess what? I followed him to his office so we could have a moment to ourselves and to my su cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin rprise, he kept working as he’s always done, ignoring interference. You see, he was wearing his professo tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen r hat and not his lover hat and I failed to appreciate it. How many women do the same? I have seen too 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 many examples of women not understanding that a man reacts differently according to each situation he is ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust in. To avoid feeling ignored, let’s leave him to his activity until he is ready to pay attention to us. y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products A Word of Advice Ladies: Wait until he is wearing his lover’s hat to demand attention and tenderness; . 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 otherwise, you will be very disappointed through no fault of his. Gents: When she complains of lack of elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip attention, remind her that you will be happy to lavish her later, when the time is appropriate to do so 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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