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Advice Pool - How Attitude is Everything
"Most overnight successes are just plain lucky. Just ask any failure." "If the only tool you have is a hammer, all problems begin to look like nails." Here's a sure 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 -fire prescription for how to fail in the game of life: Develop an attitude, personality and spirit that are critical, complaining, cynical and comparative. Demonst ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in rate these characteristics on a regular basis, and I can just about guarantee you failure in life. How to Be Critical You've heard it said that some people see the lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. world through rose-colored glasses. The person who has mastered the fine art of criticism sees the world through glasses colored by something I'd rather not mention. here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe These folks seem to live to find fault in everything with which they come in contact. Because we live in an imperfect world, something or someone can always be criti d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ized. In order to be truly successful at criticizing, these people must never offer solutions for what they don't like. This is because these folks believe people an 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 d things will be motivated to change if they are just criticized enough. It's a full-time job. Instead: There are times in life when we all need to give and receive 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 criticism. The wisest people know that you can truly benefit from useful criticism. Criticism is a tool that is used sparingly at best and needs to be coupled with s nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ome positive comments as well. How to Be Complaining A close cousin to criticism, complaining is a way of life for some. Others have raised it to an art form. Nothi 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 ng is ever good enough, not even close. If the adults who usually do this were children, they'd be accused of whining. Again, it's crucial to refrain from offering a ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi y suggestions as to what could be improved upon, much less what is appreciated. These folks would complain in heaven, if they ever got there. Instead: Define the pro ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a blem, state how it affects you and then offer suggestions for what you would like to be different. How to Be Cynical We live in an age where cynicism is thought to dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod be sophisticated. At the same time, remember when smoking was thought to be sophisticated? In order to be truly cynical, you have to be totally convinced that the wo cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin rld, the people in it, and even yourself are only out for themselves and can never be trusted. Cynicism in its purest form totally rules out the possibility of hope, tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen solutions and joy in life. David Letterman without the humor. Instead: In no way am I suggesting that we should all approach the world like naive children. Any negat 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 taken to the opposite extreme is still a negative. Instead, keeping a healthy skepticism about you protects you and allows for the possibility of hope, solutions a ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust nd true passion in life. How to Be Comparitive Anyone who has ever been compared to a sibling, teammate or co-worker knows just how fun it is to be around this kind y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products of person. "If only you were more like ... " Other good comparative things to say are: "This time is not as fun as last time," and "the way you do it here is not ne . 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 arly as good as we did it back there." Remember to say these and all comparative statements with a certain air of superiority, nose slightly turned upward for full e elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ffect. Instead: Start with what is working or is good about the situation, and then ask the powerful and rarely asked question: "How could we make this even better? 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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