Main Subject - Business

There are two prevalent approaches to the development of Datawarehouse Architectures:

Data Warehouse (DWH) bus architecture (introdu

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

ced by Ralph Kimball) According to this approach the DWH is developed i

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

Examples of combination products may in

phases. Each phase includes the development of a set of dimensional models which are linked together via conformed dimensions, thus forming a virtua

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

‘bus architecture’. Therefore, according to this approach, at the core of the DWH resides a denormalised dimensional data model, which handles data

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

t the atomic level.The major advantages of this approach are inherited from the use of the dimensional model combined with the ‘conformed dimensions’

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

Combination pro

principle. This model’s simple and symmetric structure is easily understood by Business Analysts (easier than complex normalized data models). Moreov

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

r the so called ‘star schema’ allows the efficient execution of queries (less relational joins). The ‘conformed dimensions’ principle allows for the

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

radual development of a Data Warehouse, in which all information is linked efficiently and analytics spanning different business processes or subject

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

areas are feasible. Each ‘star schema’ involves a fact table linked to a number of dimensions in a star.Three fundamental types of fact tables: trans

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

ction, periodic snapshot, and accumulating snapshot have been defined. In order to define a DWH development roadmap, Kimball introduced the concept o

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

the DWH bus matrix. The ‘bible’ on this approach is: ‘ The Data Warehouse Toolkit: The Complete Guide to Dimensional Modeling’, John Wiley

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

Following aspects would a

Sons, 2002 Ralph Kimball and Margy Ross

Corporate Information Factory – CIF (introduced by
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
"_blank">Bill Inmon)

According to this approach, the first step involves the design of a comprehensive abstract data model for

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

the Enterprise (a model mapping the way the Enterprise exploits information). Based on this abstract model, the central DWH data model is developed f

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

llowing a normalized design approach (3NF), which handles data at the atomic level.According to the Inmon approach, dimensional models embedding aggr

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

gated facts are built by querying this central atomic DWH data model and serve departmental needs (this is one of the major disagreements between the

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

Professional from academic institutions, pharmaceutical industries, health care indust

two thought leaders – read Kimball’s open letter to the data warehousing community).Both development approaches agree to the following points:

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

>Phased-iterative implementation is the way to proceed, by prioritizing on business processes or subject areas.

The use of a separate stagin

.

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

area in which extraction-transformation-cleansing of source data takes places in order to be loaded to the DWH (known as ETL operations).

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

Companies that provide selfless information through particip

e power of information resides in the atomic data, which embed all available information dimensionality.

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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