2. Dissolution documentation Case B dissolution profile
3. In vivo bioequivalence None
i. Changes being affected supplement
ii. Annual report (with long-term stability data)
Definition: This section includes changes in process type, e.g. change from wet
granulation process to direct compression.
SUPAC Guidelines and Platform Technology 37
Test documentation (Table 3.16)
Table 3.16: Test documentation required as per SUPAC guidelines level 3
Sr. No. Type of test documentation Content
1. Chemistry documentation Updated batch records
Application/compendial release requirements
A significant body of information available
One batch with three months accelerated stability data
reported in the supplement; one batch on long-term
stability data reported in an annual report.
A significant body of information not available
Up to three batches with three months accelerated
stability data reported in the supplement; one batch
on long-term stability data reported in an annual
2. Dissolution documentation Case B dissolution
i. Prior approval supplement with justification
ii. Annual report (long-term stability data)
3.6 INTRODUCTION TO PLATFORM TECHNOLOGY
A platform is a group of technology and acts as a base upon which various technologies,
applications, processes can be developed. For example, if we take the example of
computing system, then basic hardware and the operating system act as a platform on
which various programmes and applications can run. It is actually a combination of
hardware and software. There are different types of platforms. But all platforms have
a. They can be used for many candidates (that could be potential products)
b. Their establishment cost is very high and sometimes usage cost is also very high.
Nowadays the pharmaceutical industry uses these platforms to develop new
technology, new drug, new process, etc. Platform technologies are proving to be a
valuable tool in improving efficacy and quality in drug development. A platform is
considered as the most systematic method which helps in taking maximum advantage
from prior knowledge of the product to generate a new molecule. Such platforms
always have a scope of improvement. The data of new molecule which is developed
through the platform can be added to the platform and hence results in an increase in
the robustness of the platform.
But, the major problem in the way of creating and operating platform technology is
its cost. Only a company which runs several active projects can afford a platform.
Small companies with fewer projects cannot afford developing or purchasing a
platform. This is because the cost of running and operating platform technologies can
only justified if it helps in making more profit than investment. So, it is access to these
platforms that make big pharmaceutical companies enable to discover more new
medicines than small pharmaceutical companies. The platforms used in pharmaceutical
companies range from vast chemical libraries, huge genetic database and highly efficient
data screening tool to toxicology predicting platforms.
However, there is another point of view also which does not support the idea that
access to platform technology is always beneficial. It sometimes acts as a black hole in
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