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Backup Tape Usage and Replacement Schedule During the tape backup process, the tape backup media is moved across read/wri

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

te heads, alignment rollers and drive rollers. Each pass through the tape drive wears away a small amount of the oxide c

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

Examples of combination products may in

oating used to store the data. A worn tape may backup and verify without error only to fail when a file needs to be rest

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

ored. The trick is to maximize the use of the tape without allowing it to wear out.

Our recommended backup tape usage

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

and replacement schedule is derived from input from hundreds of users, tape and drive manufacturers' recommended replacem

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

Combination pro

ent schedules, and years and years of monitoring tape life and backup integrity.

In short..It works.

The schedule inclu

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

des, at any time, 12 tapes. The tapes are labeled as follows:

1) Monday 5) Friday 1

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

9) Quarter 1

2) Tuesday 6) Friday 2 10) Quarter 2

3) Wed

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

esday 7) Friday 3 11) Quarter 3

4) Thursday 8

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

) Friday 4 12) Quarter 4

The Monday through Thursday tapes are used as expected. On Fridays, one of 4 t

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

apes is used. The Friday 1,2,3 and 4 tapes are used consecutively so that you always have a backup more than 1 week old.

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

Following aspects would a

We have witnessed situations where a virus has infected a network, and corrupted files. Only going back to a pre-infec

dd to the challenges in developing combination products:

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

ion backup allows rebuilding of such files, and it often takes a few days to detect or identify such infections.

The qua

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

rter 1,2,3 and 4 tapes are used at the end of each of your fiscal quarters. These tapes are usually tapes close to the e

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

nd of their service life. This will be the last use for this tape.

This rotation schedule requires purchasing four new

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

tapes each year. At the time of purchase, the tapes are rotated into different roles. Each Friday tape is set aside awa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ting a quarterly backup role. Monday to Thursday tapes are advanced to Friday 1, 2, 3, and 4 roles. 4 new tapes are int

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

roduced into the Monday - Thursday roles.

This schedule involves using each tape 66 times. We have found this to be a r

.

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

easonable life expectancy for most backup tapes. The schedule gives you several levels of protection should a loss or co

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

Companies that provide selfless information through particip

rruption occur.

Keep in mind the tapes need to be kept warm and dry and at least the weekly and quarterly tapes off site

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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