Top Adding - Computers and Technology

And Why Should You NOT Attempt a Do It Yourself

Storage of Computer Data
Computer data is typically stored in magnetic form on Hard Disks, Magnetic Tapes, Compact Discs, DVD and RAID. Data on these storage media cou

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

ld become inaccessible owing to physical damage or corruption of the logical file system.

The logical file system is a way of organizing and accessing the file system and its contents. For example, the disk surface might be divided up

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

Examples of combination products may in

into sectors of, say, 512 KB, and each sector allocated a distinctive ID.

The file system would keep track of the sectors used by each file. These sectors would usually not be contiguous because delete operations might free up some se

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

tors that might not be sufficient to complete the next write operation. In such cases, writing would be done on sectors that are physically separate. It follows that the file system has also to keep track of which sectors are free for

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

he next write operation.

The file system logic is a complex one designed to meet the requirements of many possible read/write/delete scenarios in an optimum manner. If it gets corrupted (owing to, say, power problems or system crashes

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

Combination pro

) the contents of the disk would become indecipherable.

How Data Gets Lost
We saw above that data could become indecipherable when the file system gets corrupted. In addition to file system damage, physical damage to stora

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

e media could also lead to loss of data. Physical damage could usually cause a more serious data loss. We will look at Hard Disk Drive damage to get a picture of what could happen.

The main components of the Hard Disk Drive are the pl

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

tters on which data is stored, and the read/write heads above each platter. The read/write heads sense or record magnetic information on the platters. In normal operation, the platters rotate at extremely high speeds and there would be

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

a microscopic film of air between the platter surface and the read/write head.

If for some reason, the read/write head comes into physical contact with fast rotating platter, the magnetic media on the platter surface gets damaged. Thi

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

s event is known as a "head crash".

Another possibility is for the motor that rotates the platters to become faulty. The highly precise read/write operations would then either not be completed successfully, or fail to yield correct re

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

ults. There are other mechanical parts in the drive, any of which could fail leading to similar results.

Recovering "Lost" Data
In cases of real physical damage such as those caused by fires and floods, the data could also

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

Following aspects would a

be "really" lost. In these cases, unless you have a reliable backup of the data stored in an unaffected location, the only option would be to reconstruct the whole data from original documents or other sources.

In most other cases, ho

dd to the challenges in developing combination products:

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

ever, it would be possible to recover the "lost" data if you entrust the job immediately to expert data recovery agencies with required facilities. They might then be able to extract the raw image on the disk platters and use it to rec

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

onstruct usable data.

The recovery would typically proceed by repairing any damage to the file system, and through physical means such as replacing a damaged read/write head with a matching, healthy head, moving the disk platters to a

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

matching, healthy disk drive and/or replacing the drive's damaged PCB with a matching healthy one.

All the operations would be done in specialized "clean rooms" because even microscopic particles of dust could damage the image on the

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

isk platters. Specialist data recovery agencies would also typically be "authorized" by drive manufacturers to open the drives without voiding the warranty.

Data is packed more and more densely with each new generation of drives, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

he reconstruction could require extremely precise operations, as well as facilities like Class 100 clean rooms.

Don't Try Do It Yourself
If you try to recover the data yourself by opening the drive, you could make the data

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

permanently irrecoverable, not to mention voiding the manufacturer's warranty on the drive. The minute specks of dust present even in air-conditioned rooms could settle on the platters damaging the images on these.

Even the use of so

.

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

tware tools for data recovery, offered by utility software developers, could not only fail to recover the data but also make it more difficult (and expensive) to recover, if at all.

Additionally, steps like replacing read/write heads

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

Companies that provide selfless information through particip

nd PCBs, and moving disk platters to another drive, are best done by trained personnel. They would have gained experience of the different eventualities that could occur, and know how to take necessary precautions.

Call in the experts

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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