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Neck pain - elbow pain - triceps
Neck pain due to C7 nerve root irritation is second only 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

o C6 nerve root irritation. Those with elbow pain commonly have C6 and C7 nerve root irritation.

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

Examples of combination products may in

Triceps is supplied by the C6-C7 nerve roots, especially C7 root carried through the radial nerv

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

. Pain and spasm in the triceps together with pain and spasm in the wad of three supplied by the

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

C5 and C6 nerve roots (brachioradialis, extensor carpi radialis longus and extensor carpi radiali

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

Combination pro

brevis) will give rise to significant elbow pain commonly known as tennis elbow.

Triceps muscle

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

has three heads namely the long head, lateral head and the medial head. The lateral head and th

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

medial head arise from the posterior aspect of the arm bone (humerus). The long head is the o

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

ly part of triceps that crosses the shoulder joint since it arises from the tubercle on the shoul

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

er blade bone just below the shoulder joint.

It inserts into an area called the olecranon on the

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

back of the ulnar bone.
It acts to straighten the elbow. The long head however can bring t

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

Following aspects would a

he arm toward the body when it is spread away from the body.

Due to the constant exposure to len

dd to the challenges in developing combination products:

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

thening contractions, triceps is weak in most people especially in the presence of a C7 nerve roo

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

involvement.

Neck pain - elbow pain - hand pain - extensor digitorum
Neck pain due to C7

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

nerve root irritation will cause pain and spasm in the extensor digitorum and the other muscles o

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

the back of the forearm causing elbow pain and hand pain also. The posterior interosseous nerve

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

Professional from academic institutions, pharmaceutical industries, health care indust

carries the C7 nerve root fibers to these muscles.

This muscle arises from the lower most porti

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

n of the arm bone (humerus) known as the lateral epicondyle. It inserts into the back of all the

.

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

finger tips (distal phalanges) except for the thumb. It acts to straighten the fingers (extensi

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

Companies that provide selfless information through particip

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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