Drug Trials

Question 1

What are the basic aspects of animal testing in clinical trials?

Answer 1

• 28 day rodent and non-rodent studies
• asses toxicity and maximum no effect dose
• long term toxicity studies to determine long term effects e.g. Cancer
• in vitro testing for mutagenic effects on bacteria or mammalian cells
• reproduction toxicity tests (rodent and non-rodent)

Question 2

What are the main aspects of review for pharmaceutical testing?

Answer 2

• drub substance evaluated under storage conditions that tests its thermal stability and if appropriate sensitivity to moisture
• long term, accelerated and intermediate studies
• tablet manufactured validation protocols
• quality control tests made on all formulations including appearances and microbial contamination

Question 3

What does the clinical trials certificate application require?

Answer 3

• applications made to the Medicines Control Agency
• supporting data on safety and quality
• experimental and biological data including human data

Question 4

Describe the aspects of phase 1 clinical trials.

Answer 4

• drug first introduced to humans
• small group of healthy male volunteers (20-80)
• low doses administered
  
  • determined from pre-clinical data
  • increased in short cohorts

Question 5

What are the main aims of phase 1 clinical trials?

Answer 5

• to determine base properties such as
  
  • ADME
• mainly tests the drug’s safety profile

Question 6

What are the aspects of phase 2 clinical trials?

Answer 6

• carried on 200-300 volunteer patients
• studies are well controlled and closely monitored
• gives the preliminary data of drug’s efficacy
• ascertain correct dosage levels for therapeutic effects
• also ascertain short term side- effects and associated risks

Question 7

What are the aspects of phase 3 clinical trials?

Answer 7

• involved a large number of patients in clinics and hospitals
• carried out after phase 2 trials suggest efficacy
• studies are expanded controlled and uncontrolled trials where physicians monitor the patients closely to gather addition information on efficacy and safety
• mainly carried out double blind with a placebo or the drug against marketed products

Question 8

Describe phase 4 clinical trials.

Answer 8

• carried out after market authorisation
• used to evaluate long-term effects and monitor drug safety
• can be used to determine other uses for the drug

Question 9

What is involved in the patent application process?

Answer 9

• patent runs for 20 years following the first patent application
• Paris convention allows a 12 month period where work can continue on the invention
• at the end of the 12 months the application is examined
• application is published and open to the public
• if all objects are met on 4.5 years applicant is granted the patent

Question 10

What is the marketing authorisation application?

Answer 10

• was known as product license
• two routes in Europe for authorisation of medicinal products
• the centralised procedure and the mutual recognition procedure
• applications outside Europe made to individual states

Question 11

What is the centralised procedure?

Answer 11

• applications made to the European Medicines Evaluation Agency
• leads to the granting of a European marketing authorisation
• procedure is compulsory for products derived from biotechnology but optional for other medicinal products

Question 12

What is the mutual recognition procedure?

Answer 12

• applications made to member states chosen by applicant
• operates by mutual recognition of national marketing marketing authorisations
• advantageous if applicant doesn’t want to market product to all countries covered by the EMEA

Question 13

What are the basic aspects of drug research?

Answer 13

• find a suitable synthetic route
• examine chemical stability
• look at the compounds ability to be formulated into a dosage form
• initial pharmacology studies
• ADME in animals