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There’s this old lady (Mrs. Mann), who lives next door to my mother, and believe it or not she has 11 cats. Her place is not like one of those homes that you s

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

ee on reality TV shows where cats are run amok fouling up and stentching out the house. Everything is neat an tidy and the lady obviously takes great care of

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

Examples of combination products may in

er feline companions, but it’s the awful howling and wailing that’s disturbing my mother’s sleep at night.

Most of the moggies were pretty well behaved until

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

bout a month ago. Okay, so there was the occasional cat fight outside the bedroom window, but that was more not than often. Anyway, my mother suggested her ne

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

ighbor check to make sure her wailing whiskers were healthy and not crying because of medical problems. According to Mum, Mrs. Mann looked a little upset at f

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

Combination pro

rst by such a suggestion, as if to insinuate she wasn’t taking care of her animals. My mother went on to explain that many cats can have latent problems that

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

re not always apparent from just looking at the animals and that it might be a good idea to get a vet take a look.

Mrs. Mann did as my mother suggested and it

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

appeared that one of her cats had feline acne and it was this one that was doing all the wailing at night. In fact, it was having a knock on effect among the

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

other pets because when the troubled one started it’s crying they all joined in. A kind of cat’s choir if you like!

Apparently, it was the introduction of a

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

tray that was the culprit. A lost and crying kitten on the way back from the shops one day was more that old Mrs. Mann could bear, and she took the kitty home

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

with her to join the rest of the family.

Whenever taking a stray cat into any home, one of the first jobs should be a trip to the local vets to get the animal

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

Following aspects would a

checked over. Even our well groomed moggies can pick up fleas, worms and all manner of other cat complaints, so just imagine what kind of health problems an

dd to the challenges in developing combination products:

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

nchecked stray could bring into the home?

Mrs. Mann’s big heart cost her a big cheque as she had to get all of the animals checked over in order to find the c

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

lprit. Feline acne is not always obvious and can sometimes look like a couple of other complaints that mimic the condition, which are ringworm (dermatophytosis

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

) and demodecosis. These were ruled out by the vet and feline acne was diagnosed as the problem. This was somewhat of a relief for ole Mrs. Mann as demodecos

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

s could have spread through all the animals, and then she really would have a job on her hands.

Demodecosis is extremely contagious among cats and the way thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

is treated is by using a kind of lime sulfur dip and it can prove to be a very uncomfortable treatment for the cat.

In this case, the feline acne was treatab

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

le by a topical treatment which was a benzoyl peroxide shampoo. There are other treatments but the vet will usually advise what to use on a case by case basis

.

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

Vitamin A ointment (Retin-A, Rx), metronidazole gel and mupirocin ointment are perhaps the other most common recommendations.

In some cases a topical treatm

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

Companies that provide selfless information through particip

nt alone is not sufficient, and it’s necessary to use systemic antibiotics or corticosteroids, but once again, the veterinary surgeon is the one to advise here

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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