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Advice Pool - The Shout
One day, a wise teacher asked his students, "Why is at the time someone angry, he will speak loudly and even shout?" One 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 of the students, after thinking quiet long, raised his hand and then answered, "Because at that time he has lost his pati ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in nce; that's why he shouts." The teacher asked again, "Just at that moment, the person he speaks to is in front of him. W lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. hy should he shout? Can't he speak softly?" Most of the students gave the answers, which in their consideration were corr here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ct. However, there was no delightful answer. The teacher then said, "When there are two people in an angry situation, th d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro e distance between their hearts becomes so far although physically they are close. Therefore, they have to shout to reach 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 the quite far distance. The strange thing is the louder they shout the angrier they are. In that case, the distance of th 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 eir hearts is automatically further. That's why, they then have to shout louder and louder again." Next, the teacher ask nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically d, "Contrary, what will happen if there are two people who fall in love each other? They never shout. Whenever they speak 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 , their voices are so soft and gentle. No matter how soft the voices are, both of them can hear each other so clearly. Wh ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi is that?" the teacher asked his student again while watching at his students. They were seen to think very deeply, but ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a one of them have the courage to give the answer. The teacher explained, "Because their hearts are so close, their hearts dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod have no distance. Until at last there is no single word need to be said. One look is quite enough for them to understand cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin n what they want to say." The teacher still continued, "When you are angry, don't let your heart create any distance. At tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen that time, don't say any words, which possibly invite distance between your hearts. As possible as you can, keep in sile 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 t is the wise thing to do, because time will help you to hold your anger." Patience is the pearl of life that we ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust must have. As we face other person who is emotional, we need patience. Moreover, when we are offended, angry, and emotio y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products al, we also need a brake, that is patience. Patience needs mature mentality in order to hold and control our attitude, so . 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 that we are not fallen down into irrational act that loses us. To reach the real success, we must have patie elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ce. Without patience, we will be easily trapped into negative communication and hard to create a nice social relationship 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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