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Whereas a medical autopsy is essentially a physical examination of the deceased, a psychological autopsy is essentially a mental state examination of the deceased.

There are a nu

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

mber of reasons why it might be appropriate to undertake a psychological autopsy, however, the most common is to assist in determining nature of death.

Estimates suggest that in

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

Examples of combination products may in

up to 20% of cases presented to a medical examiner/coroner the precise mode of death is unclear. A psychological autopsy can help address this ambiguity and establish whether deat

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

h was as a result of natural causes, suicide, accident or murder.

Methodology

Within the context of a forensic investigation a psychological autopsy is employed as a data

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

collection tool. The most common source being interview data obtained from the family and friends of the deceased.

Obtaining the medical history of the deceased is also a centra

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

Combination pro

l component of the psychological autopsy. Interviewing the doctor of the deceased and/or examining medical records is, therefore another important data collection source.

The nat

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

ure of the information collected would usually include the following:

Biographical information (age, marital status, occupation).

personal information (relationships, lifestyle,

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

alcohol/drug use, sources of stress).

Secondary information (family history, police records, diaries).

It's important to note that as with most data collection protocols conduc

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

ted within a psychological framework, different methodological approaches exist. A useful way to think of this is in terms of means to an end.

The end is by and large the same i.

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

e. it is hoped that collectively, information obtained will as Berman & Litman (1993) describe result in a:

'Postdictive analysis yielding an opinion giving a logical understa

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

nding of the relationship between the deceased and the events and behaviors that preceded the death'.

The means by which you reach this end can, however, differ slightly, for

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

Following aspects would a

example, the clinical approach Vs the equivocal death analysis approach favored by FBI.

Validity

While there is certainly evidence to support the validity of psychologic

dd to the challenges in developing combination products:

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

al autopsies per se e.g. Brent et al (1993), it also needs to be recognised that in general, the term psychological autopsy is not particularly well defined nor standardised for o

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

perational use.

One major concern is that there does not appear to be systematic guidelines in place regarding training and best practice. Another, is that depending on the natur

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

e of the case under review, the person carrying out the psychological autopsy may not have the depth of forensic knowledge required to help inform the cause of death e.g. blood sp

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

latter analysis.

It is for these reasons that it is probably sensible to view the psychological autopsy as just one of the many investigative tools available within a cause of de

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

Professional from academic institutions, pharmaceutical industries, health care indust

ath investigation.

If you would like to find out more about psychological autopsies and other fascinating topics within forensic psychology, you can do so by visiting

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

ttp://www.all-about-forensic-psychology.com/" target="_new">http://www.all-about-forensic-psychology.com/

If you would like to read more information from the world of forensi

.

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

c psychology you can subscribe to my free newsletter. Regular features include an articles and links section, conference listings, news from the field and study guide.

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

Companies that provide selfless information through particip

ttp://www.all-about-forensic-psychology.com/forensic-psychology-newsletter.html" target="_new">http://www.all-about-forensic-psychology.com/forensic-psychology-newsletter.html

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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