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Useful Articles - How a Three Letter Word Kills Good Relationships
"You know, I really do love fish!" My friend Steve came up with this profound comment as we were about to tuck into the gastronomic offerings before us in a crowded downtown restaurant. I raised my eyebrows. Well, on the face of it, Steve sure wasn't kidding. He 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 lost
no time in matching words with action as he attacked the luscious fried sole with cream sauce with unbelievable gusto. But I know my friend is a philosopher at heart, and I wasn't going to let him get away with it so easily. "Steve," I said. "You're doing ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in a great job with
that fish. I envy your efficiency. But..." "But what?" "What do you mean that you LOVE it?" "I sure do," Steve assured me. "Could eat it for breakfast lunch and supper. I believe I could almost live on it." "Yeah," I retorted. "And lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. for the sake of your
unquenchable love, the lives of how many fish are sniffed out every day? Steve, you don't love FISH. You love YOURSELF." And my friend was forced to admit I was right. Now, let's switch focus a bit. Let's talk a little about Pete here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe , another good friend of mine. (OK, OK, I'll come clean. In real life, I don't have a friend called Steve nor one called Pete. If I did, I wouldn't be gossiping about them like this, would I? I hate gossip. Fortunately, though, I've a reasonably good imagination, and d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro I'm trying to put across some pretty
important concepts here... Forgive me? Good...) Couple who are always squabblingPete has been married for ten years or more, and he and his good wife, Jane are almost always squabbling. 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 To tell the truth, I've never known anything like it. It's either he insulting her, or she insulting him. In private or public, it seems to make little difference; each trying to find a juicier epithet still to hurl at the other. And yet... Ever since I've 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 known him, Pete has been protesting that he
loves Jane dearly. And you know something? He does. I should know. He's MY friend. True, at one time, I was skeptical. If Pete said he loved his wife, I could hardly doubt it, but I thought it was like Steve and his beloved nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically fish. Now I know better. Good - so how do I know? Alright, I'll tell you. A few years ago, something of a medical nature was apparently bothering Jane a bit, so off she went to her doctor for a check-up. She wasn't expecting anything particularly dramatic, but 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 what she heard from the physician
that day was a bombshell, to put it very mildly. "Jane, I don't like to frighten you, but this is life threatening. Very , very serious. However, time is still on our side. The next two months will be critical. You must follow the tr ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi atment program to the letter, and get plenty
of rest. And keep praying..." Do you think there was any bickering in Steve and Jane's household during the following two months? Not on your life! Blissful feeling of intimacyPete ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a 's single-minded concern for his wife's health and
comfort, if predictable, was complete. And if a pain wracked Jane did allow an occasional hurtful remark to pass her lips, he found it pretty easy to ignore it. Ironically, this was, in some ways, the happiest period dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod of
the marriage. A blissful feeling of intimacy, such as neither partner had ever dreamed possible, enveloped the unsuspecting couple. Pete's obsession with Jane's welfare left him with no time for extraneous thoughts, and Jane's appreciation and admiration grew stronger cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin day by day. Two month's later, they were back at the doctor's. Can you imagine the overwhelming relief when he pronounced: "The danger's over!"? Business as usual...And the next day - business as usual! Petty bickering, na tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen me-calling, all kinds of verbal barbs and arrows. Well, if
that brings them a little contentment in life...everyone to their own taste! But seriously, what makes them do it? Can they really be contented that way? More pointedly, how could a couple that had reached su 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 ch great heights slip back overnight? It all boils down to a critical three-letter word. We call it the EGO. Is the Ego really so bad? Not always. If by "ego" we mean "self-esteem", it's indispensable. Many people say that we can't start to love ot ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust hers until we love ourselves first.
That's perfectly true - IF we're talking about the right kind of self-love. But if my Ego means my needs, my honor, my sensitivities, always come first (and probably middle and last), boy, we're playing with dynamite! Sure, P y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ete loves Jane, and Jane loves Pete. Always did,
always will. If one would disappear from the other's life, he or she would know all about it! So what's the problem?Then what's the problem? Why does it take a medical crisis to cre . 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 ate a little bit of peace and harmony in their home?
What prevents this at other times? And what about US? What blocks the harmony that we seek in our homes, the peaceful cooperation we want in our workplaces? The Ego that insists that I'm right, that will not y elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ield on
the most trivial issue. The Ego that demands the honor that's due to me. The Ego that pursues justice at all costs, irrespective of everything it knocks down on the way! And for the sake of that pompous ass of an Ego, we're prepared to sacrifice everything! 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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