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Running a few 5K races this summer is an excellent way to challenge yourself. Once you've decided to start racing, you should incorporate t

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

raining runs and cross-training into your regular workout routine. Combine running, strength training, core strength, and other forms of ca

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

Examples of combination products may in

rdio into your routine to improve your performance when race day arrives.

Make your training fun and challenging by tracking your distance

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

s and times for each training run. Incorporate indoor and outdoor runs, sprints, hills, and distance to keep training runs interesting. Whe

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

n it's time to strength train, be sure to work the entire body as opposed to focusing only on your legs. The running motion incorporates up

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

Combination pro

per body, lower body, and core muscle groups and training the entire body will improve your performance.

I found two studies that talked a

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

bout strength training and running being used together in a training program. In the first study, it was found that explosive strength trai

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

ning improved the 5K time endurance athletes [1]. The second study indicated that endurance athletes could benefit from strength training i

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

f they were doing certain activities that required fast-twitch muscle fibers [2].

These studies were done on trained endurance athletes an

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

d indicated some positive correlations between strength training and running. Most athletes, beginners and advanced, should benefit from st

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

ength training as a cross-training activity to improve 5K time [1], although endurance runners who run 4-6 days per week may not see notabl

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

Following aspects would a

e improvement in running performance for longer races [2].

If you have just signed up for one of your first races or you haven't raced in

dd to the challenges in developing combination products:

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

a long time, you definitely want to start training runs at least 4 weeks before race day (for a 5K). If the race you've chosen is a longer

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

than 5K, plan on training at least 8 weeks prior to the race.

You can design your own race training program with a simple calender and a f

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

ew ideas. As a beginner in moderate physical condition, running a 5K, you can run twice per week and strength train twice per week for the

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

first four weeks. For the second four weeks, include 3 runs in your training regimen and strength train twice per week.

If you have any qu

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

Professional from academic institutions, pharmaceutical industries, health care indust

estions, let me know by sending me an email!

Good Luck!

References
1. Leena Paavolainen1, Keijo H?kkinen2, Ismo H?m?l?inen1, Ari Nu

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

mmela1, and Heikki Rusko Journal of Applied Physiology Vol. 86, Issue 5, 1527-1533, May 1999 Explosive-strength training improves

.

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

5-km running time by improving running economy and muscle power
2. R. C. Hickson, B. A. Dvorak, E. M. Gorostiaga, T. T. Kurowski, and

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

Companies that provide selfless information through particip

C. Foster J Appl Physiol, Nov 1988; 65: 2285 - 2290 Potential for strength and endurance training to amplify endurance performanc

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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