Module 8
Data Requirements for Abridged Applications and Specialised Products
Aim
The purpose of this Module is to provide an understanding of the diversity of abridged applications, and to outline the data requirements for a variety of different new dosage forms and new indications. The Module also covers consideration of the data requirements for certain specialised products.
Learning outcomes
- Students will identify the chemical/pharmaceutical, preclinical and clinical data required for line extensions taking into account the interaction between the various parts of a dossier.
- Students will define the requirements for bridging data in various situations.
- Students will examine the data requirements for line extensions, generic applications and for specialised products.
- Students will evaluate the data requirements for Supplemental Applications in the USA.
Outline of Module topics
- Discussion of various types of abridged applications including new routes of administration, new dosage forms and new indications
- Chemical and pharmaceutical requirements for abridged applications including Drug Master Files and Comparability Protocols
- Bioequivalence
- Small-molecule generics
- Data requirements for biosimilar products
- Preclinical requirements for abridged applications
- Clinical data requirements for line extensions
- Discussion of particular product categories such as novel delivery systems, sustained release products, fixed-dose combination products and inhalation products
- Requirements for drug/device combinations
- Radiopharmaceuticals
- Blood products
- Herbal medicines
