Pre-clinical Development of Vaccines Flashcards
1
Q
Stages in vaccine development
A
- basic research
- preclinical development (in vitro and animal studies)
- clinical trials
2
Q
List various role-players in vaccine development
A
- public and private product developers
- oversight (safety/efficacy/ethics)
- manufacturers
- governments and international agencies
- emerging role of international PPPs and donors
3
Q
Two major approaches to vaccine development
A
- entirely new vaccines
- modifications to existing vaccines
4
Q
Describe the approach to developing entirely new vaccines
A
- new disease
- new technology
- apply new technology to old vaccine
- eg Hep B/HIV
5
Q
Describe the approach to modifying an existing vaccine
A
- new strains (influenza)
- combination vaccines
- liquid vs freeze dried
- manufacturing process
- adjuvants
6
Q
Describe preclinical efficacy/potency testing
A
- a diverse set of activites
- conducted in v controlled scientific environment
- must convince regulators that product has potential
- different for different vaccines
- significant overlap in data of clinical trial phases
7
Q
Two phases of toxicology testing
A
- ongoing during research (un-regulated)
- formal on final product (highly regulated)
8
Q
Things considered in formal toxicology testing
A
- vaccine and adjuvant
- performed under GLP
- guided by product
- different animals
- doses (increments, numbers and routes)
- local and systemic toxicology)
- enhancement
- mutagenesis
- sterility
- biodistribution
- half life
9
Q
Preclinical toxicology endpoints
A
- physical examination
- evaluation of injection site for irritation and histopathology
- body weights
- food and water consumption
- ophthalmologic observation
- clinical pathology
- gross observations and organ weight at necroscopy
- histopathology evaluation
- relevant immunogenicity
10
Q
What does GMP include?
A
- quality management
- personnel
- premises and equipment
- documentation
- production
- quality control
- contract manufacture and analysis
- complaints and product recall
- self-inspection
