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Full of Articles - Lasik Facts
The latest medical answer to solve the complications of visionary problems has been the LASIK eye surgery. A number o
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
f people who are tired of wearing glasses and contact lenses have opted for LASIK eye surgery. They have opted for a
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ermanent solution to their eye problems. However, it is crucial to know certain facts about this new development befo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e an individual goes ahead to try a LASIK surgery, as it is not wise to take chances with the most sensitive sense of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the body.
To begin with, individuals are required to know that a LASIK surgery is a laser refractive surgery that in
To begin with, individuals are required to know that a LASIK surgery is a laser refractive surgery that in
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
olves the reshaping of the cornea. Cornea is a very delicate part of the eyes and needs proper care and operative pro
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
cedures to ensure success in the healing process of an effective LASIK surgery. A LASIK surgery is usually not recomm
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
nded for people below 18 years of age as the vision before that age does not develop completely. In some cases, the m
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nimum age might even be restricted to 21. It is not recommended for pregnant women and people who are undergoing spec
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
fic prescribed drugs such as oral prednisone or Accutane. The general health of the person needs to be good. Individu
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ls suffering from myopia can postpone the surgery until the refraction is stabilized. Otherwise, it might require rep
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
eated procedures, called "refinement".
Although, tried and tested by many patients, LASIK surgery does not guarantee
Although, tried and tested by many patients, LASIK surgery does not guarantee
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
that patients will never require glasses in the future. According to case studies, there have been instances in which
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
people have continued with their glasses. It is essential to know all the consequences and complications that might o
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
cur after the surgery. The suggestions and opinions of an experienced and qualified doctor might be taken for this re
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
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
arding the eligibility for the surgery as well as its aftereffects. The risks of LASIK surgery include overcorrection
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
, undercorrection, inflammation, infections, and damage of the cornea, and hence require sufficient care. Although th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
statistics of the complications after the surgery may be less common and variable according to individual conditions
.
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
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
it is not always wise to only bank on the statistics. It is better to evaluate individual problem levels. It is reco
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
mended to consider the other alternatives as well before opting for a LASIK surgery unless it is absolutely necessary
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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