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Main Subject - Life Lesson: Some Thoughts On Work
Most everyone spends a good portion of their days putting their
hand to something that will gene 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 rate the resources they have
decided they need, to live the life they have decided they want. W ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in hat puzzles me though, is why so many people pick something to put their hand to that leaves them lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. feeling empty inside. It is really the state of things that we all must grit our teeth and go here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe to work? It is really the state of things that we die a
little each morning only to be jolted ba d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ck alive when we leave the office? I know a man who is a very senior investment advisor. -He ha 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 tes it. -He makes an above average amount of money. -He keeps doing it. -He calls it a 'grind' 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 . I've asked him why he doesn't just stop and do something else that will bring some satisfactio nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically n, maybe even do something he loves. He told me 'satisfaction in what you put your hand to' is n 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 ot
reality and to stop dreaming. Stop dreaming? Isn't dreaming what got us the airplane? Isn't ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi dreaming what got us electricity and modern communications? Isn't dreaming what is needed to cure ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a cancer? I wonder if Albert Einstein ever thought going to work was 'a grind'. I wonder if Sir dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod Isaac Newton would roll out of bed with a groan and a big rock in his stomach. Maybe the reason cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin why so few of us do what we love is because we
have all been programmed to think 'work and love tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ' don't go
together. I think most of us don't even think about the two
concepts in the same tho 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 ught wave. The reality of 'loving what you do' doesn't exist in most people's internal scripting. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust I know a few people who do what they love. Most of them are hiding and you don't see them very y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products often. These people dwell far out of the mainstream, living in their own reality. I joined them a . 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 few years ago after I realized scripts can be rewritten, and my act two and three can be whateve elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip r I want them to be. My coffee bean grinder was made for grinding. Last time I checked, I wasn't 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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