L1: Drug development process Flashcards
The drug development process is:
Complex and lengthy
The drug development process requires:
Interdisciplinary collaborative effort
The drug development process requires demonstration of:
Animal and human efficacy and safety
The risk of drug failure is highest during:
Discovery/preclinical development
What is the overall success rate for getting a drug through to approval?
1.6%
What are the major reasons for attrition in drug development
Toxicology and clinical safety
Who are involved in the drug development phase
Regulatory authorities
Preclinical and clinical testing is regulated from
ICH guidelines
What is ADME an abbreviation for
Absorption, Distribution, Metabolism and Elimination
What is needed to enter Phase I clinical trials
Pharmacology (in vitro/in vivo), safety pharmacology, animal PK
What is the investigator’s brochure?
Compilation of the clinical and nonclinical data
What is essential to find out as early as possible:
The therapeutic range/ the right dose
What is MABEL an abbreviation for=
The Minimum Anticipated Biological Effect Level
What is NOAEL an abbreviation for?
No Observed Adverse Effect Level
What is one of the main purposes of the CMC phase?
Process development and scale-up
