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You don't need to have completed a university degree to write a non-fiction article, book or historical novel. You do, however, need to know the basics of keeping records of your research. Yes, even when writing fiction. As Dan Brown can tell you, historical f

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

iction can be taken to count with every fact. Rightly or wrongly, facts need to be accurate and sources quotable. Keeping a papertrail and bibliography will, hopefully, keep you on the right side of the track.

Papertrails

Simplicity in itself. Note down wher

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

Examples of combination products may in

you sourced your information and when [date everything]. As websites come and go with unpredictable regularity, file a copy, neatly labelled, of text sourced from the Internet. The papertrail is the precursor or back-up of the official bibliography. [Tip: whe

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

n bookmarking websites, consider making them available offline. This way, should the page vanish overnight, you should still have a copy of the version you saved.]

In the case of books, journals, newspaper and hearsay, jot down the pertinent facts, such as bo

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

k title, author, publisher and ISBN. For journals, record the volume and issue numbers, date published, publisher, and article author. Similar again for newspapers or any other written research. Record of hearsay will, of course, need the name of the person pr

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

Combination pro

oviding the information, date and location, plus, their relativity to the subject. Are they an expert in the subject field? Is their opinion subjective or objective? Are their comments off-the-cuff or supported by research, experience or yet more hearsay evide

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

ce?

Storing the papertrail is vitally important. Especially if you're the type of writer whose desk, handbag or coat pockets are stuffed with scraps of paper, sticky notes, ink-blotted serviettes and scribble-covered business cards. Get yourself a pocket-size

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

notebook and pen, and keep it on your person [or in your handbag/briefcase] at all times. That's the mess cleared up. Next, keep an exercise or notebook on your desk or filed with your research notes, and copy your source details into it. If you have the room

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

invest in a filing cabinet, hanging files and manilla folders. The more organised you are with these notes the easier they are to find later.

You could do all the above on your computer, but data stored in this way is easier corrupted [on purpose or by accid

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

ent] and easier lost. A papertrail may seem old-fashioned yet the evidence it holds can sink or swim anything from an academic study to a best-selling popular novel.

Bibliographies

The end result of a good paper-trail is an easy to organise bibliography that

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

saves you time and headaches in its creation. If you are writing or planning to write a non-fiction piece of any kind you will need a bibliography. Readers of your work will want to know where they can go for further information. More than this though, a bibli

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

Following aspects would a

ography offers proof that you actually did research! Check other bibliographies in your field of writing/research and with your potential publisher for tips on style. As with anything, style varies, and the more academic your work the more particular the requi

dd to the challenges in developing combination products:

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

ements.

The basic bibliography style is alphabetical by author name followed by title, publisher and publishing date. You can categorise the list by chapter and/or reference chronology as well. Confirm requirements with your chosen style guide before you star

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

t.

If you have used references throughout your text, make sure you have these clearly listed in the bibliography along with all authors/editors, titles, publishers and publishing dates. You might also need such bits and pieces as chapter and page numbers and

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

ournal issue information. If you're in possession of a well-maintained papertrail, this won't be an issue.

Some authors also include notes that further specify evidence origin and reliability. Others will include appendices and beautifully tended indices. 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

need for these depends entirely on the subject, field of endeavour and detail-obsessiveness of the author.

Students from primary [elementary] school up are taught to provide bibliographies with many of their projects in order to combat plagiarism and make th

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

Professional from academic institutions, pharmaceutical industries, health care indust

m aware of this valuable research tool early. By the time they reach university, theory has it, the need for bibliographies is ingrained into their psyche. I'm not entirely sure of the success of this, but the principal is sound.

In today's world of easy acce

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

ss information, readers not only want to read the truth, they'll take authors to count on any inaccuracies. Correct facts and transparent sources are no longer the backbone of non-fiction and academic work alone, but are also a solid avenue of support for the

.

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

eneral fiction writer as well. As more people realise their writing ability, whether or not they have a university degree behind them, the importance of keeping records rises. As the internet widens its tentacles, so do the levels of disinformation. By keeping

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

Companies that provide selfless information through particip

records accurately writers protect themselves and their readers from falsehood and clumsy mistakes, and provide a trail of checkable facts. A trail that is in demand by the general public, academia, literary world, and the judicial system!

Just ask Dan Brown

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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