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A database is a collection of interrelated data’s stored in a database server; these data’s will be stored in the form of tables. The primary aim of database is to provide a way to store and retrieve database information in fast and efficien

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

t manner.

There are number of characteristics that differs from traditional file management system. In file system approach, each user defines and implements the needed files for a specific application to run. For example in sales departmen

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

Examples of combination products may in

of an enterprise, One user will be maintaining the details of how many sales personnel are there in the sales department and their grades, these details will be stored and maintained in a separate file.

Another user will be maintaining the

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

salesperson salary details working in the concern, the detailed salary report will be stored and maintained in a separate file. Although both of the users are interested in the data’s of the salespersons they will be having their details in

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

a separate files and they need different programs to manipulate their files. This will lead to wastage of space and redundancy or replication of data’s, which may lead to confusion, sharing of data among various users is not possible, data i

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

Combination pro

consistency may occur. These files will not be having any inter-relationship among the data’s stored in these files. Therefore in traditional file processing every user will be defining their own constraints and implement the files needed fo

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 applications.

In database approach, a single repository of data is maintained that is defined once and then accessed by many users. The fundamental characteristic of database approach is that the database system not only contains data

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

s but it contains complete definition or description of the database structure and constraints. These definitions are stored in a system catalog, which contains the information about the structure and definitions of the database. The informa

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

ion stored in the catalog is called the metadata, it describes the primary database. Hence this approach will work on any type of database for example, insurance database, Airlines, banking database, Finance details, and Enterprise informati

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

on database. But in traditional file processing system the application is developed for a specific purpose and they will access specific database only.

The other main characteristic of the database is that it will allow multiple users to ac

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

ess the database at the same time and sharing of data is possible. The database must include concurrency control software to ensure that several users trying to update the same data at the same time, it should maintain in a controlled manner

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

Following aspects would a

In file system approach many programmers will be creating files over a long period and various files have different format, in various application languages.

Therefore there is possibility of information getting duplicated, this redundancy

dd to the challenges in developing combination products:

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

is storing same data multiple times leads to higher costs and wastage of space. This may result in data inconsistency in the application, this is because update is done to some of the files only and not all the files. Moreover in database a

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

proach multiple views can be created. View is a tailored representation of information contained in one or more tables. View is also called as “Virtual table” because view does not contain physically stored records and will not occupy any sp

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

ce.

A multi-user database whose users have variety of applications must provide facilities for defining multiple views. In traditional file system, if any changes are made to the structure of the files if will affect all the programs, so ch

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

anges to the structure of a file may require changing of all programs that access the file. But in case of database approach the structure of the database is stored separately in the system catalog from the access of the application programs

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

Professional from academic institutions, pharmaceutical industries, health care indust

This property is known as program-data independence.

Database can be used to provide persistent storage for program objects and data structures that resulted in object oriented database approach. Traditional systems suffered from impedance

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

mismatch problem and difficulty in accessing the data, which is avoided in object oriented database system. Database can be used to represent complex relationships among data’s as well as to retrieve and update related data easily and effici

.

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

ently.

It is possible to define and enforce integrity constraints for the data’s stored in the database. The database also provides facilities for recovering hardware and software failures. The backup and recovery subsystem is responsible f

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

Companies that provide selfless information through particip

r recovery. It reduces the application development time considerably when compared to the file system approach and availability of up-to-date information of all the users. It also provides security to the data’s stored in the database system

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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