E-Articles - Health and Fitness

The most important part of caring for the visually impaired is understanding what level of acceptance each patient has regarding their vision loss. M

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

ost patients referred by their doctors or on their own are emotionally ready to accept assistance. They have moved passed the grieving process and ac

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

Examples of combination products may in

ept the fact that using adaptive methods and devices will allow them to continue performing their activities of daily living.

However, success in th

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

erapy may be minimal when therapist and/or patients do not identify the patient’s poor coping capabilities. Patients and therapists may “hit a wall”

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

ith rehabilitation efforts and neither may be able to identify the rationale behind the problem. The psychosocial implication arising from poor copin

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

Combination pro

skills can lead to a bad outcome.

Conversely, when the therapist has the ability to identify the patient’s level of understanding in the coping 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

cess, both are more likely to achieve success with vision rehab.

I aim at having multiple resources available for patients and their family members.

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

Many times, peer counseling accelerates the patient’s involvement and level of understanding in vision therapy. For example my patient “GS” was griev

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

ing the loss of her vision. When GS reached out to us, she needed guidance not only to regain her independence but achieve her desire to read bedtime

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

stories to her child. GS began vision therapy simultaneously with peer counseling and found help from both settings.

GS was more motivated about par

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

icipating in vision therapy knowing members of her peer group had themselves gone through vision therapy and had successful results. GS benefited in

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

Following aspects would a

the participation of both vision rehab and counseling as she gained skills with coping from both groups. She gained knowledge and understanding about

dd to the challenges in developing combination products:

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

the numerous adaptations for day-to-day activities; available resources to help with transportation, free services such as large print books, and rad

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

io reading services. She was able to call on peers whenever she found it difficult to cope and gained control of her life one day at a time. With ass

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

stance from her peer group members, GS was able to understand and follow the work assignments given to her by the Occupational Therapist. By the end

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

f our vision rehabilitation, GS was familiar with her recovery process and had slowly recovered the things she lost and the ability to read to her ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

ild for the very first time!

She completed vision rehab after having met her goals but identified that her rehabilitation process may continue for t

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

e rest of her life. For example, as she regained the ability to read, her efforts may continue month after month so as to increase reading speed. GS

.

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

became aware of many other patients and members of her peer counseling group who had surpassed their expectations of what could be accomplished, such

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

Companies that provide selfless information through particip

as writing a book or using the computer. GS acknowledged it all happens in steps, and patients require patience and realistic expectations to succeed

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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