Biowavers

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

permeability criteria.

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

phenomenon.

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

be similar to the population.

2. Descriptive biostatistics: These are used to explain the basic features of the data.

They also provide simple summaries of the data.

Application of Biostatistics

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

is divided into four steps:

1. Early planning and management of the project

2. Document Preparation

3. Dossier publishing

4. Dossier submission

During the planning stage applicants are recommended to use the following tools:

• Checklist • Glossary

• Template • Timeline table

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

follows:

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.