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Q – I recently got back into weight training and have been getting very sore several days after, is this normal?

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

A – It sounds like you are suffering from a case of DOMS or Delayed Onset Muscle Soreness. This usually occurs

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

Examples of combination products may in

between 24 – 72 hours after exercise and is often experienced after an extended layoff from training or after t

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

king part in an activity that you aren’t used to. It is a relatively familiar situation amongst both novice and

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

elite athletes and most of us will experience it to some degree at some stage after exercise. Some of the common

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

Combination pro

symptoms of DOMS include, tenderness, pain, restriction in range of motion, inflammation and a temporary loss of

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

performance. Despite research in the area an actual etiology (cause) for the condition is still unknown, though

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

there are several theories. Some suggested causes include lactic acid, muscle spasm, connective tissue or muscle

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

damage, and more recently the role of free radicals. It is more likely that combinations of several of these th

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

ories are the cause rather than a singular one.

Though the exact cause of DOMS is still unclear, what is known

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

is the type of muscle action that is primarily responsible. Eccentric muscle actions are those when we lower wei

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

Following aspects would a

ghts (such as the down phase of a squat), or have to slow down movement (running downhill for example). These ty

dd to the challenges in developing combination products:

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

es of movement cause the muscle to be lengthened under tension and the amount of soreness will be dictated by th

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

e intensity and duration of muscle action.

Treatment of DOMS is tricky, as many conventional approaches such as

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

ice, stretching, homeopathy and ultrasound seem to be ineffective. Some reduction in reported symptoms has been

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

shown with the use of NSAID’s (Non-steroidal anti-inflammatory drugs, such as Ibuprofen). Though one of the simp

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

Professional from academic institutions, pharmaceutical industries, health care indust

est ways to ease the soreness is with physical activity. To maintain your training programme focus on working di

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

fferent movement patterns or body parts in your training sessions and avoid training areas or movements where yo

.

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

have painful soreness. Exercise training helps protect and reduce DOMS in subsequent exercise. To help prevent

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

Companies that provide selfless information through particip

painful soreness get back into your weight training with lighter weights and build up to higher intensity levels

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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