Lecture 3

Degree to which a final product matches the predefined specifications.

What is quality?

\
* Identity: Active ingredient
* Purity: Not contaminated with potentially harmful substances
* Potency: Usually 90–110% of the labelled amount
* Uniformity: Consistency of colour, shape, size
* Bioavailability: Interchangeable products?
* Stability: Ensuring medicine activity for stated period

\
What are the 6 characteristics of quality? 

\
* Product 
* reactive

\
What is quality control?

\
* Process right way
* preventative

\
What is quality assurance?

\
* Product selection – shelf life, stability, bioavailability
* Selection of appropriate suppliers - 
* Product certification – GMP

\
How can you assure high quality assurance?

International standardization organization

What does ISO stand for?

20,000

\
Approximately how many ISO standards are there?

\
* GMP manufacturing
* GLP laboratory
* GCP clinical
* GSP storage
* GDP distribution
* GRP review

\
What are the different Good X Practices?

\
* Traceability
* Accountability

\
What do the G x P standards ensure?

\
* ISO help companies learn how to achieve quality etc
* GxP regulate to protect consumers from harm – mandatory

\
What is the difference between ISO and GxP standards?

\
* Q10 pharmaceutical Quality System

\
What ICH Q does GxP fall into?

\
* Product performance and product quality

\
What does PQs refer to?

Chemistry, manufacturing and controls: ensure all reg criteria relating to quality are fulfilled.

\
What do CMC reg affairs do?

\
* To satisfy all reg requirements have to be met before the new compound is deemed ready to be tested for First-in-Human trials

\
What is the aim of preclinical development? 

\

1. Formulation studies’
2. Synthesis scale-up
3. Safety/toxicity studies (non-clinical)

\
What are the three main areas of activity?

\
* To define parameters for safe transition to human clinical trials

\
What is one important need for the preclinical safety and toxicology studies? 

\
* Effects of the IMP (Investigational medicinal product) on the body and how the effects are produced

\
What does the term pharmacodynamics refer to?

\
* Indirect or downstream effects of a drug on a biological system, beyond primary effect

\
What does the term secondary pharmacodynamics refer to?

\
* Absorption
* Distribution
* Metabolism
* Excretion
* Bioavailability

What does ADMEB stand for in pharmacokinetics?

\
When do drug interactions occur?

\
* When administration of one drug alters the response to another drug – potential for harm

\
* Animal toxicological testing
* Alternative in vitro toxicological testing
* Toxicological testing on isolated tissues/organs 
* In silico modelling

\
What tests are performed when assessing toxicity?

\
* Acute toxicity
* Chronic toxicity (Repeat-dose)
* Reproductive toxicity and teratogenicity (3 diff dosage levels)
* Mutagenicity
* Carcinogenicity
* Other

\
What are the 6 types of toxicity?

No observed adverse effect level

\
What does NOAEL stand for in chronic toxicity testing?

On long term rodent study, an either another long term rodent study or short/medium in vivo rodent test system

\
What is the basic principle of carcinogenicity testing?

Differentiate between mechanical effects of drug administration/chemical effects and true toxicological effects

\
What is a local tolerance test used for?

\
* Replacement
* Reduction
* Refinement

What are the 3Rs?

\
\
* European centre for the Validation of Alternative Methods

What does ECVAM stand for?

Environmental Risk Assessment

What does ERA stand for?