Advice Pool - Health and Fitness

Anti – Reflection coats stop these reflections and make the spectacles look cosmet

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

ically more attractive, but also reduce glare through the lens, and make wearing t

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

Examples of combination products may in

hem easier particularly when night driving and you are sensitive to headlights fro

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

m oncoming traffic. The AR coat is a very thin layer on the surface of the lens;

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

it is designed to be the thickness of a quarter of the wavelength of light – so th

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

Combination pro

at when light reflects off the lens, it is half a wavelength out of synchronisatio

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

n with the reflections from the surface of the coating, and therefore neutralises

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

or offsets the reflections.

Most AR coatings are multilayered so that they cancel

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

out light from all parts of the visual spectrum – however they are never 100% effi

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

cient and a small part of the spectrum does not get neutralised – this is why they

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

often have a pale blue/green appearance depending on the constitution of the chem

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

Following aspects would a

istry used and as a consequence which part of the spectrum is not blocked.

The te

dd to the challenges in developing combination products:

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

m MAR coating simply refers to multi anti-reflection coating. HMAR refers to MAR w

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

ith an additional hard coat on top.

For general purpose glasses and sunglasses (o

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

r tinted glasses), the cost of the anti-reflection probablt doesn't justify its ad

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

dition - but if you are either susceptible to light - and in particular to rapid c

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

Professional from academic institutions, pharmaceutical industries, health care indust

anges in light conditions, for example when driving - this can be a wise and safe

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

investment. The coating can be added after the fact as well - so if you have a fa

.

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

vorite pair of spectacles, and find that glare and reflections are affecting you,

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

Companies that provide selfless information through particip

it is possible to take them on to an options shop and have the coating added later

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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