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Numbers
Numbers followed by units of measure should never be written out.

Bad: It was a one GB hard drive
Good: It was a 1 GB hard drive

Single digit numbers ( zero through nin

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

e) should usually be written out.

Example: There were nine cables.

References to numbers as they appear in text should be in quotes, or bold, and should match the way they are represented in t

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

Examples of combination products may in

hat text.

Example: There were nine cables numbered "1" through "9".
Example: Go to the menu and select ten or more.

Numbers that start a sentence should be written out

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

mple: Thirteen revisions have been created. Single digits compared with multiple digits do not need to be written out:

Example: Approximately 1 in 300 modems failed in the first year.

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

umbers enumerating nouns that are defined by a number should be written out.

Example: There were twenty-seven 802.11 abg wireless pc cards in stock.

Units of measurements
Abbreviat

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

Combination pro

ions of units should not be followed by a period unless they are at the end of a sentence.

Abbreviations of units should be lower case except in the following situations:

Units of measure named for a person sh

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

uld be upper case (e.g.: kHz).

Bytes are abbreviated B, bits b (e.g.: 5 GB hard drive and 1Gb Ethernet.

Metric abbreviations are case-sensitive, so uppercase and lowercase letters have different meanings

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

mm stands for millimeter (one-thousandth of a meter)

Mm stands for megameter (one million meters) The plural of the abbreviation of unit of measure is the same as the singular (i.e.: never add

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

an "s")

Good: 100 GB
Bad: 100 GBs

Units of computer memory
The computer industry commonly refers to:

A factor of 1024 (2 to the power of 10) as "k"
1024 squar

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

d (2 to the power of 20) as "M"

1024 cubed (2 to the power of 10) as "G" The above units of computer memory are distinctly different from the metric abbreviations:-

k that stands for kilo

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

and means thousand (1,000 or 10 to the power of

3)

M that stands for mega and means million (1,000,000 or 10 to the power

of 6)

G that stands for giga and means billion (1,000,000,000 or 10 to the po

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

Following aspects would a

wer

of 9) This is why units of computer memory should never be written out as "kilo", "mega" or "giga"

Measurements
There should always be one blank space between a number and a unit (prefe

dd to the challenges in developing combination products:

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

ably a non-breaking space)

Whenever possible, give numerical values in comparisons and explanations to avoid ambiguity:

Bad: Older hard drives were smaller.
Better: Hard drives manufactured bef

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

ore 1999 had less than 1 GB of storage

capacity. Only compare the value of items if they are of the same unit of measurement (i.e.: Don't compare apples to oranges).

Bad: The 5400 rpm hard dr

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

ive is faster than the 100 GB hard drive.

Better: The 5400 rpm 50 GB hard drive performed better in the seek test

than the 2700 rpm 100 GB hard drive. As a related matter, use the same units of meas

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

rement in comparisons.

Not so good: To compare and contrast the performance of this process on

an idle system with 256 MB, 512 MB and 1 GB of RAM...
Better: To compare and contrast the performanc

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

Professional from academic institutions, pharmaceutical industries, health care indust

e of this process on an idle

system with 256 MB, 512 MB and 1024 MB of RAM...

Exception: if the measurement remains the same and the unit changes, it

can be used for emphasis (e.g. it costs $10 per year wh

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

ere it used to cost

about $10 per month)

Dates
Use the dd Mon yyyy format because it is less ambiguous, and globaly recognizable.

Example: 08 Jun 2006

Use a non-breaking sp

.

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

ce between the day and month, and between the month and year.

Acronyms
Common acronyms

HTML: Hyper text markup language
PC: Personal computer
(ADD TO THIS LIST)

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

Companies that provide selfless information through particip

If an acronym is not in the above list it must be written out upon first usage and followed by the acronym in parenthesis

Example: Three letter acronyms (TLAs) are abundant in technical writing.

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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