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Digg It - CD/DVD Master Preparation Tips
“CD/DVD Master” is the disc you provide to your CD/DVD vendor for replication or duplication of that media. Here
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
are some helpful tips for creating a high quality master:
- Always use high quality media. All media is not th
- Always use high quality media. All media is not th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e same. Do your research and choose a brand that will produce a high quality disc consistently.
- Avoid burning
- Avoid burning
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
from a network source. If your source files are on a network drive, copy the files to your local hard drive bef
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ore burning a disc. If you cannot move the files to your local drive, please use the “Copy To Hard Drive First”
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
feature. Your burning software will create a temporary image file during the burning process. When the burn 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
complete, the temporary file is deleted.
- Avoid burning on a laptop computer running on battery power. Fluctua
- Avoid burning on a laptop computer running on battery power. Fluctua
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
tions in available power may yield poor results.
- Always “Finalize” your disc. If you use the drag and drop in
- Always “Finalize” your disc. If you use the drag and drop in
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
terface that is built into some operating systems (Windows XP), be sure to select “finalize disc”. This will inc
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
rease the “read” compatibility in other CD-ROM drives.
- Don’t use packet-writing method to burn master disc. T
- Don’t use packet-writing method to burn master disc. T
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is method is most common with burner drives that have “re-write” capabilities. It is similar to the “drag-and-dr
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
op” method described above. This burn method produces discs that cannot be read on many CD-ROM drives. We canno
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t accept a master that is burned to a ReWritable (CD-/+RW or DVD+RW) disc.
- Avoid impact or movement of the dri
- Avoid impact or movement of the dri
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ve during burn. This can cause the laser to skip or jump a track, which will produce errors or a bad disc.
- Us
- Us
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e “burn-proof” feature if available. This feature allows the drive to slow down the burn speed in the event 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
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
computer cannot supply data fast enough. This can increase the total burn time, but the quality of the disc will
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
be greater.
- Avoid having multiple applications open when burning, especially those that access the internet o
- Avoid having multiple applications open when burning, especially those that access the internet o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r network. This can hinder your computer’s ability to “feed” data to the burner drive at the proper rate. Poor
.
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
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
quality discs and burn rejects could be the result.
There are exceptions and variables to all the statements abo
There are exceptions and variables to all the statements abo
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ve. If you have any questions regarding how to burn your master, feel free to contact the author of this article
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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