Advice Pool - Health and Fitness

As an eye surgeon this is a question I am frequently asked by patients. (I am often tempted

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

to reply "Yes - as long as you think your pectoral muscles are up to it, and you don't get i

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nto too much of a flap".) However the more sensible answer is that in most cases there are n

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

o restrictions on flying after cataract surgery. It is usually quite safe to do so, even rel

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

atively soon after the procedure. It is though always wise to ask your own eye specialist b

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

efore doing so, and to have their reassurances. Only they will know the specific details and

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

requirements of your case.

The air conditioning within an aircraft may make the eye feel a

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

ittle dry and irritable but this is not harmful. If this occurs using some artificial tear

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

lubricant drops may be helpful, along with the normal post-operative eye drops prescribed 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

your surgeon. Avoid rubbing the eye if it is irritable. Instead closing the eye gently may

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

be helpful as this reduces evaporation from the eye surface and the eyelids offer natural pr

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

otection.

Do not fly away from post-operative supervision until your ophthalmic team is hap

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

py that the eye has sufficiently recovered from surgery. If you need to travel out of reach

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

of their care during the post-operative recovery period check that you are in a location whe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e an eye specialist is available, in case problems arise. The specialist who has performed t

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

he surgery may be able to recommend a colleague at the new location. It does no harm to ask

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

.

The only situation where flying may be dangerous after eye surgery is when a bubble of ga

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s has been placed within the eye. This is not done during normal cataract surgery. It is som

.

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

etimes done for operations on the retina, e.g. retinal detachment repair. Gas within the eye

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

will expand if a plane flies at high altitude and this can be harmful to the eye and vision

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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