Advice Pool - Health and Fitness

Another day, another great workout. Since I had started kickboxing, I had kicked and punched my way to a great summer body. The results showed at

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

the beach, in the club and in Shana’s eyes. I loved the way she looked at me nowadays. I had a date with her after my kickboxing routine and I w

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

Examples of combination products may in

s just driving the car around the block to pick her up.

“Hi!” I said as she opened the door. “Hey” she gushed effusively. Then a quick peck late

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

r, we were on the way to the car. She had her arm around my biceps and it felt great. Inside the car, “You look great nowadays,” Shana said. I’ve

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

been working out my way to that perfect summer body” I said, “and my new workout is great fun.”

“What kind of workout is that?” Shana asked as I

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

Combination pro

stepped on the accelerator on the open road. “I practice a kickboxing routine,” I said. I have been punching and kicking my way to summer fitness

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

this last month. “Kickboxing is the latest, hottest trend in the fitness world” I continued. “It is a fun way to a fitter body and a great way t

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

improve self esteem.”

“You sure look hot,” Shana purred as she tried to navigate her way closer to me, “Tell me more.” I turned the bend and co

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

tinued, “when I first joined kickboxing classes, I had to be very careful with my kickboxing routine.” I had to be careful not to give in to peer

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

pressure and exercise too much.” “I have slowly but surely worked my way to peak form.”

“Isn’t a step aerobic workout a great way to achieve th

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

se results as well?” Shana asked. It is a great way to burn calories, but step aerobics burn 300-400 calories per workout and cardio kickboxing b

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

Following aspects would a

rns about 500-800 calories per workout,” I countered, plus it is much more fun.” “I feel like kicking open the door to a kickboxing class myself,

dd to the challenges in developing combination products:

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

after seeing your new body, John,” Shana said.

“A great idea” I said, “Your figure would be that much more perfect.” I continued, “But remember

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

to keep a few things in mind. You have a high current fitness level, but remember to take it easy at first as many classes do not offer kickboxin

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

routines on a progression basis.”

“Tell me what I need to know,” Shana said suddenly more serious, aware now that a new window of fitness was a

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

bout to open for her, “Since you know quite a bit, John.” “Okay,” I said, “in the two minutes before we reach your favorite Thai restaurant, I wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

l tell you what you need to know.”

“Typically, in classes, warm up with stretches, pushups and jumping jacks. Alternate with punches, hand strik

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

s and kicks and then combine all three. After the main section of the routine cool down with floor exercises. Wear loose clothes and drink plenty

.

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

of water. That’s it in a tiny nutshell,” I said, as I braked the car to a stop in front of our favorite Thai restaurant. “I can’t wait to kick a

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

Companies that provide selfless information through particip

d punch my way to summer fitness,” Shana said, as I opened the door of my car and we looked forward to fine wine, Thai cuisine and the good life.

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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