Exercise 1. Comprehension questions. Bioavailability Studies

Phase IV

Bioavailability Studies

Process Development for Manufacturing and Quality Control

Phase III Clinical Trials

Phase II Clinical Trials

Phase I Clinical Trials

Preclinical Testing

Stages in drug discovery and development

Discovery/Basic Research

• Synthesis and Extraction – the process of identifying new molecules with the potential to produce a desired change in a biological system

• Biological Screening and Pharmacological Testing – studies to explore the pharmacological activity and therapeutic potential of compounds

• Toxicology and Safety Testing – tests to determine the potential risk a compound poses to humans and the environment, involve use of animals, tissue cultures or other test systems

• Pharmaceutical Dosage Formulation and Stability – the process of turning an active compound into a form and strength suitable for human use

Regulatory Review: IND

• Application to regulatory authority to use compound in human testing. In the US the compound is then called an Investigational New Drug (IND)

• Testing of a new compound in 20-80 healthy human volunteers to determine tolerance, pharmacological effects, and absorption, distribution, metabolism and excretion (ADME) patterns

• Trials in 100-300 patients with the targeted condition to determine effectiveness in treating disease or medical condition and short term risks

• Trials on 1000-5000 patients to determine clinical benefit and incidence of adverse reactions

• Engineering and manufacturing design activities to establish capacity to produce in large volumes and to ensure stability, uniformity and overall quality

• Use of healthy volunteers to show that formulation used in trials is equivalent to product to be marketed

Regulatory Review: NDA

• Application for approval to market a new drug. In the US this is called a New Drug Application (NDA)

• Post marketing trials to identify undetected adverse effects and long term morbidity and mortality profile

1. What is one of the fastest growing healthcare sectors?

2. What have evolved into innovative platforms?

3. What can drug delivery systems improve?

4. What can drug delivery system boost?

5. What have drug delivery technologies become an integral part of?

6. What have the advances in drug delivery technologies gone hand in hand with?

7. What capacity do new drug delivery systems have?

8. What do novel drug delivery technologies offer?

9. What are the stages in drug discovery and development?

10. What are synthesis and extraction?

11. What are biological screening and pharmacological testing?

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