Lecture 3

Degree to which a final product matches the predefined specifications.

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?