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All of you NCIS or CSI fans have watched the TV shows and heard of terminologies professed by the medical examiners, Dr. Donald “Ducky” Mall

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

ard or Dr. Alex Woods, such as rigor mortis. Then they tell you the approximate time of death of the individual when investigating the deat

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

Examples of combination products may in

h of a person at the scene of a crime.

What is rigor mortis and how do parts of the body that have or have not entered the rigor state determine the tim

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

e of death?

In this article, I will discuss what rigor mortis is and explain how time of death is determined in a dead body, or sometimes called “stiff,”

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

when investigators are called to the scene of a crime.

What is rigor mortis?

Rigor mortis refers to the stiffening and contraction

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

Combination pro

of muscles caused by chemical reactions that take place in the muscle cells following death.

The reason that a body becomes stiff or rigid after death is

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

due to the absence of molecules called adenosine triphosphate (ATP) from the muscle cells. ATP is the energy currency of all cells in the body especiall

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

y muscle cells. Without ATP, muscles can not contract. The presence and maintenance of ATP levels is dependent upon the steady supply of oxygen and nutr

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

ents, which are lost when the heart stops. When ATP levels diminish, muscles contract and stiffen up, producing the rigidity of rigor mortis. When there

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

is loss of rigidity and the appearance of flaccidity of the muscles, this is due to the decomposition aspect of the putrefaction process of the muscle ce

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

lls and tissues.

How is time of death determined?

Rigor mortis sets in throughout the entire body at the same time following death. Howev

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

Following aspects would a

er, the muscles become rigid at different rates in a predictable pattern. In ideal conditions (i.e. room temperature is 70 degree Fahrenheit), rigor mort

dd to the challenges in developing combination products:

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

s sets in as follows:

• About 2 hours after death, rigor mortis is first detected in the small muscles of the face and neck and proceeds downward in a ce

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

phalocaudal (head-to-toe) direction to the larger muscles.
• Between 8 and 12 hours after death, the body is completely rigid and is fixed in the pos

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

ition of death.
• 18 hours thereafter, the body remains fixed. This is called the rigid state of rigor mortis.
• After about 30 hours fo

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

llowing death, the process of rigor reverses itself, and rigidity is lost in the order in which it appeared. That is, loss of rigidity begins in the face

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

Professional from academic institutions, pharmaceutical industries, health care indust

and neck and proceeds from the head-to-toe direction.
• About 38 to 42 hours following death, the muscles become relaxed when entering the flaccid

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

state of rigor mortis.

The states of rigor mortis are only useful for determining the time of death during the first 36 to 48 hours after death

.

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

under ideal conditions.

So whenever “Alex Woods” of CSI: Miami is called to the crime scene and mentions that death occurred about two hours ago

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

Companies that provide selfless information through particip

from the time she firsts examines the body at the crime scene, she bases this on the fact that rigor has set in face and neck but not the rest of the body

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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