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Sanity Saver# 6 Slow Down There is more to life than increasing its speed. Gandhi Most of us live as if we are careening down a freeway. Think about how much you miss when yo 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 u’re traveling at warp speed. We need to take the first available exit and pull into a quiet country lane, slow down and reflect on our lives. There is a saying in Thailand, “Life is so short-- ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in e must move very slowly.” Since we can’t slow down the things around us we try to speed ourselves up. We hurry, rush, we hustle. We run ourselves ragged trying to get ahead or stay even or to lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. atch up. And then we occasionally encounter someone who seems to have time for everything and for everyone. He doesn’t hurry. He doesn’t seem stressed, rushed or impatient. It’s almost as if here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe e’s got nothing to do yet he gets so much done. Consider for a moment, stressed people are always in a hurry. People who hurry are always stressed. People who don’t hurry aren’t frustrated. P d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro eople who aren’t frustrated don’t hurry. Which comes first? Does hurry cause stress or does it result from it? Is it possible that our attitude and our approach to life actually affect how fas 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 our time passes? Is it possible that we’re a little like a hamster on a treadmill who by running faster and faster succeeds only in making our world spin ever faster. And perhaps if we conscio 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 sly slow ourselves down and become a little more patient, a little more aware we can slow ourselves down and find that we are able to accomplish more with less hurry. I have to admit that slowin nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically down is a challenge. I was recently on my way to a meditation retreat to learn how to slow down when I was pulled over by a state trooper. I was in such a hurry to learn how to slow down that 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 I got a ticket for speeding. So I’m not saying that slowing down is an easy thing to do. It isn’t. Many of us think that fast is equated with happy, but it isn’t. In fact the faster we go the ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi more stress we have in our lives. Ask yourself, “What’s my hurry?” Hurry is your enemy. We do a lot of rushing around trying to squeeze in more stuff than we should, leading us to do all of it ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a less well and making it all less enjoyable. Why hurry? You probably answer because you have to. But that’s simply not true. Don’t fill in all the time with new activities, but rather let the dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod est of what you do proceed more leisurely. By doing this, you can slow down. This will make you both more effective and more fulfilled. Our information overload has conditioned us to require m cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ore speed, more stimulation to feel engaged and not bored. We’re on the fast track. Do you know where your time goes? Most of us budget our money down to the last penny, but very few people bud tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen et their time. But let’s fact it, time is much more important than money. We spend it, we waste it and we “kill it.” Time is a finite resource, but we behave as if it were infinite. Consider 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 or a moment, if I said I would give you $86,400 every day for the rest of your life, but you had to spend it wisely or you’d lose it what would you do? Of course you’d do everything possible to ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust pend the money wisely. Yet each of us is given 86,400 seconds every day and the same proposition challenges us, spend it wisely or lose it. You’ll never get back the hours you waste at work, et y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products c. that time is gone forever. The way you spend your time separates the successful people from those who continue to struggle. If you are continually amazed at people who live a calmer life tha . 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 you do, take charge of your time. If time is flying you have to be the pilot. Guard it as a treasured possession—because it is. Spend it thoughtfully because you can’t get it back. But slowin elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip down requires courage and commitment. It means swimming against the societal tide. We must learn when to “do” and when to “be.” How to strike a vibrant balance between the two becomes crucial 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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