Biowavers are the exemptions that are granted by USFDA from conducting human
bioequivalence studies. Biowavers reduce the need for bioequivalence studies. They
are given when in vitro studies data provides sufficient estimate of a relative in vivo
performance of two products. These are given when API meets certain solubility and
BIOSTATISTICS IN PHARMACEUTICAL PRODUCT DEVELOPMENT
Statistics is the science which deals with collection, tabulation and classification of
numerical facts as the basis for explanation, description and comparison of the
Biostatistics is the branch of statistics concerned with mathematical facts and data
related to biological events. Sir Francis Galton is the Father of biostatistics.
There are two types of biostatistics:
1. Inferential biostatistics: It is the methods of generalising a larger group. The
generalization is based on information about a sample. The sample is considered to
2. Descriptive biostatistics: These are used to explain the basic features of the data.
They also provide simple summaries of the data.
After the Kefauver Harris drug amendments, it is compulsory for the firms to prove
the safety of the drug with suitable statistical evidence. Statistics is involved in all
stages of drug development, i.e. from drug discovery to post-marketing processes.
DATA PRESENTATION FOR FDA SUBMISSIONS
The FDA accepts electronic submissions. The electronic submission's regulatory process
1. Early planning and management of the project
During the planning stage applicants are recommended to use the following tools:
MANAGEMENT OF CLINICAL STUDIES
The clinical trial management requires efficient management. Clinical trial consists of
a series of stages. Each of the stages requires effective management. The stages are as
1. Initiating 2. Planning 3. Executing
4. Monitoring and controlling 5. Analysis and reporting
Managing these five stages is the most effective way of managing clinical studies.
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