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Digg It - Build Up, Don't Knock Down
This is sometimes described as learning to say 'Yes, and .. .' rather than 'Yes, but ... '. Any new idea may includ 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 e lots of problematic elements, and the newer the idea, the more problematic it is likely to be. It is therefore ve ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ry easy to kill ideas by highlighting their weaknesses. However, this will often 'throw the baby out with the bath lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. water'. Even the silliest, weirdest or most impracticable of ideas will contain one or two per cent of potentially here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe viable material or can be used as what de Bono referred to as an 'intermediate impossible' - a stepping-stone to o d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ther, more directly usable ideas. 'Building' techniques are extremely powerful, often very portable and can have v 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 ery positive secondary effects:
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 onexpert's misunderstanding, a tedious discussion with the office bore or an accidental meeting - and get useful id nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically eas from it.
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 ther people involved will also tend to feel encouraged by having their tentative ideas valued and being helped to b ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ild them into realistic and acceptable plans.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a n, from which they learn a lot and which leaves them valuing you and the organisation.
Here are some s dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod uggestions that people often find useful for building on existing ideas:
cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ects ('Yes, that idea would let us .. .').
tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ackled ('That idea raises an interesting problem. I wonder how we could .. .').
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 er ideas.
ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust epresent it in a different medium (draw it, role-play it, sculpt it, etc.).
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products from someone else's viewpoint, from a different hierarchical level, in different contexts or on different time-sca . 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 les).
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip e at work in a more or less automatic way - the more practised you are, the more automatic they become).
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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