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Top Articles - Devotional Thought - Rocks
One of the benefits of living in a coastal country in Africa is that 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 the beach is not far away. I have always found the sound of the ocean ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in to have a calming effect when I am in a stressful situation. And aft lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. er this particular week, I needed the calming effect! I had wondered here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ll week if I was really where God wanted to me be and if He could use d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro me here. While sitting on the beach, I leaned back and my hand hit 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 a rock. I picked it up and saw that it could have been a good skippin 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 g stone except the edges were not rounded. They were jagged and rough nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically It would take years of tides to smooth the edges of this stone. I re 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 alized that I was a lot like that rock. I have a lot of jagged edges, ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi too. Leaning back on the other arm, my hand hit another rock. The s ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a imilarity between the two amazed me. They could have been from the sa dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod e quarry. But this second stone was smaller and smoother — perfect fo cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin r a skipping stone. I sensed God’s message: Yes, it takes time and wo tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen rk, but I too can be a useful vessel for Him. I have to be patient as 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 God sends circumstances into my life that smooth out my rough edges. ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust Perhaps the difficulties of this week were part of the smoothing proc y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ess in my life. I still have those rocks. They sit on my bookshelf t . 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 o encourage me to continue to be willing to be changed. They serve as elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip a reminder that “all of us are the work of God’s hand.” (Isaiah 64:8 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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