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Almost everything emits, reflects, or transmits some kind of light. The Electromagnetic (EM) Spectrum is the measurement of the frequency range of EM radiation of an object. The frequency is measured in

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

wavelengths. The wavelength ranges can extend from the size of an atom to thousands of kilometers.

The long wavelengths are low frequency and are the Radio, Microwave, and Infrared waves. The short wa

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

Examples of combination products may in

velengths are the high frequency Ultraviolet, X-ray and Gamma Rays. The Visible Spectrum, or Optical Spectrum, is the range of the Electromagnetic Spectrum that is visible by the human eye.

The Visible

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

pectrum has no clear boundaries from one color to the next but is generally described in the following ranges:

Violet 380-450nm (*nanometers)
Blue 450-495nm
Green 495-570nm
Yellow 570-590n

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

m
Orange 590-620nm
Red 620-750nm

*Nanometer - a unit of length in the metric system, equal to one billionth of a meter, which is the current SI base unit of length. It can be written in scienti

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

Combination pro

ic notations as 1?10-9 m (engineering notation) or 1 E-9 m (exponential notation), both meaning 1/1,000,000,000 meters

History

Newton divided the spectrum into seven named colors: red, orange, yellow, g

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

reen, blue, indigo, and violet, or ROY G. BIV. Originally only five primary colors were named: red, yellow, green, blue and violet, but later he added indigo and orange to have seven colors. The need for

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

the number seven was derived from the belief that it should match the number of known planets, number of days in a week and the number of notes on a major scale. This theory was derived from ancient Gre

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

k Sophist philosophy.

The word Spectrum is Latin for apparition, and was coined by Newton during his experiments with light. He observed that sunlight passing though a prism produced the apparition or s

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

pectrum or, in other words, a band of colors.

Sir Isaac Newton wrote Optick,s released in 1704, hailed as one of the earliest explanations of the Spectrum.

Optics

The field of optics usually describes

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

he behavior of visible, infrared, and ultraviolet light; however because light is an electromagnetic wave, analogous phenomena occur in X-rays, microwaves, radio waves, and other forms of electromagnetic

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

Following aspects would a

radiation. Optics can thus be regarded as a sub-field of electromagnetism.

Camera Vision

In vision applications that use camera technology the optical fields of visible, infrared and ultraviolet are the

dd to the challenges in developing combination products:

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

most widely used, and with the implementation of specialized optics, filters, and lighting many solutions to imaging issues can be found. Infrared Radiation (IR) is a wavelength longer than visible lig

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

t but shorter than radio waves (750nm to 1nm). Ultraviolet (UV) is shorter than visible light but longer than X-Ray (400nm to 200nm Near UV, NUV). Most cameras will fall in the near IR or near UV range

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

and with the use of specialized lighting (LED’s), enhancement of the wavelengths is possible.

Infrared (IR) camera technology is very common in military applications and Ultraviolet (UV) solutions are us

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

d in various machine vision, and industrial imaging applications. There are also digital cameras, such as Firewire 1394 which exploit the use of Ultraviolet (UV). Sony Electronics, Inc. offers the XCDSX

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

Professional from academic institutions, pharmaceutical industries, health care indust

910UV camera featuring Firewire 1394, digital camera technology. This camera is ideal for use in demanding markets such as semiconductor inspection, ultraviolet microscopy, FA precision inspection and su

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

rface inspection applications.

Hitachi Kokusai Electric Inc. offers the KP-F120, a Near IR (NIR), high resolution, progressive scan camera with Camera Link, USB2.0, Firewire 1394 or LVDS digital camera i

.

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

terfaces. The spectral response extends beyond 1000 nm. This camera is appropriate for a wide range of applications including machine vision, agricultural inspection, medical diagnostics and research, an

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

Companies that provide selfless information through particip

d microscopy.

There are many cameras that fall into the near Infared (IR) and near Ultraviolet (UV) ranges. They are used in a variety of applications and provide many solutions from military to medical

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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