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Digg It - Notes for Newbies - Introduction
You have made a life-changing decision. You have decided you want to make some serious money so you can live a lifestyle most people have only dreamed of. :-) Where 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 do you go from here? If you are new to this business of direct marketing, and remember we were all Newbies once upon a time, you sometimes no doubt feel a bit ove ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in rwhelmed by the amount of information you have been hit with. Let’s look at what you have done – probably:
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ied ads in the ‘Business opportunities’ section of your Sunday newspaper here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ast one (and probably more than one) seminar d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ve subscribed to at least one (and probably more than one) newsletter 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 n on one of the guru’s websites 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 arketing’ business nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically read about the importance of ‘testing’ 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 Now, it’s important to realize that most of this information is very, very good and some of it is great – some of it ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi will make you very wealthy, indeed :-) if only you can figure out how to make it work for you. And here is the key – how do you go about sorting out all this very ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a , very good, very useful information, then use it to help you make a pile of money so you can start living the lifestyle you have dreamed about even since you first dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod thought about this? You need a plan. You need to get all this information organized so you can concentrate on the important things. You need to decide what you are cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin going to do first, what you are going to do next, then after that, then after that until your business is up and running and beginning to earn big money for you. tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen Some of this information is useful now to help you set up your business and some of it will be useful later on when you want to fine-tune some part of it. What I w 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 nt to talk about in these articles are some things I think will be helpful for you as you go about organizing all this information. These are tips that have helped ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust me along the way. I’m sure you will find them profitable. Remember, also, to have fun. This is not the drudgery of the old nine-to-five rat race, working for someb y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ody else. This is your business, your lifestyle. Enjoy this exciting new adventure! That’s all for this time. See you soon. Over the next three sessions we shall . 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 alk about the three most important things you must build before you can create a highly profitable direct marketing business. These are: (1) your market, (2) your p elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip roduct, (3) your list. Thanks for listening :-) William Rice-Johnston Copyright © 2006 Mary Rice-Johnston & Golden Goose Direct. All rights reserved 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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