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E-Folder - The Sound of Silence
'Nature abhors a vacuum.' In science, things move from where they are to where t 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 hey are not. Gas will spread to fill a space, liquids will mix naturally, and ai ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in pressure will try to equalize. Have you ever seen a movie set in space where th lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. e spaceship has a whole and everything gets sucked out into space? That's becaus here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe space is a vacuum and nature quickly tries to fill that vacuum with the air fro d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro inside the ship. People are the same way with silence. Silences can be awkward 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 and uncomfortable, and people will quickly try to speak to fill the void. When 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 sed properly however, silence can be a very powerful thing. If you are in a con nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically versation with someone, your first reaction might be to begin speaking as soon a 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 they finish. If it's an animated conversation, you might even start talking bef ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi re they finish speaking. If you do this, you do two things. First, if you have y ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a our response ready to go as soon as they stopped talking, you probably stopped l dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod stening to them before they finished. Second, you miss an opportunity to connect cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin with the person. Pausing before you respond lets the other person know that yo tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen have been listening, and that you are thinking about what they just said. If yo 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 're doing the technique right, you actually will be thinking about what they sai ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust d. The pause also deflates heated discussions and gives you some control. In ne y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products otiating, a common piece of advice is after the price has been stated and the or . 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 der has been asked for, the first person to speak loses. Get comfortable with si elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ence, and you will dramatically increase your power when interacting with others 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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