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Advice Pool - Relationship Leper
I was married the first time (ominous words...the first time) for 16 years. In retrospect, that marriage probably could have been saved if we'd utilized couns 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 eling and found some great relationship material which may have been published at the time. Ah well, hindsight. During my dating stint post-divorce, some of ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in which was internet contact, I communicated with an interesting and attractive man. Sooner than later, I learned that he'd been married, and divorced, 5 times. lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. Warning, warning. DANGER, flailing my arms around in robotic pantomime. I ended that direction in short order. Obviously he wasn't good relationship materi here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe al. I married again. That relationship of 6 years ended with his drug usage and an affair. Sometimes I can be surprisingly dumb for as smart as I am? HE on d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro y had one divorce behind him. Maybe I should have asked Mr. Fiver different questions. Third marriage. And to my horror, THIRD DIVORCE. I felt shellshocked 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 terribly embarrassed. Memories of my fast judgment of Mr. Fiver came flooding back to me, how quickly I'd axed him without giving him a chance. With t 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 ree divorces under my belt, I quailed at the thought of being similarly, and immediately, axed without a chance to prove my good character and relationship-wor nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically thiness. How terribly unfair that would be. Although I take at least half the responsibility of my first divorce, nos. 2 and 3 were more the other's fault by 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 a landslide. (We'll ignore the fact that I did waltz myself into those relationships, shall we? That's a topic for a different article!) I had mental images ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi of "go-see's" in front of potential dates. "I've been divorced three times," I imagined myself declaring, and then coughing up their dust as they ran for the ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a hills. Frankly, I wouldn't have blamed them. Now perhaps I just hadn't quite hit the buzzer mark for interested suitors. Or perhaps there was something the dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod saw in me that made them decide to explore further upon hearing those dreaded words - I spilled them as quickly as I could reasonably bring it up in a convers cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ation: HiMyNameIsLauraI'veBeenDivorcedThreeTimesAndYou? Ahem. Whatever it was, I found that no one screamed "Exit, stage left!" and left me standing next to tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen a little poof of smoke. Maybe they were shellshocked too, and unable to move? Actually, they asked pertinent questions regarding my divorces and listened to 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 my explanations. I was very upfront with them concerning what I felt my part was in the marriage demises, minus the ad nauseum. I also shared in a general way ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust what I had learned. Dating excursions thus continued for awhile, with me feeling comfortable that I wasn't dismissed as a relationship leper! Ever feel like y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products you're a relationship leper? Have you learned from past mistakes and able to articulate your past in a way that doesn't frighten prospective dates? Currently . 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 my (third) ex-husband and I have reconciled, and we had our divorce annulled. It's as if we were never divorced. I am very happy that we've resolved the pro elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip blems that led up to our divorce...and relieved that my score card dropped back to 3-2. Upon that realization came the next one: time to retire my score card 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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