What Does
Safety Pharmacology Mean?
Safety pharmacology is a branch of pharmacology that assesses the potential adverse effects of new pharmaceutical products. It specializes in detecting and investigating the biochemical and physiologic effects of new chemical entities (NCEs) in relation to therapeutic use.
Safeopedia Explains Safety Pharmacology
Therapeiutic drugs must be able to achieve their salutary effects without producing an undue amount of harm to the user. Safety pharmacology identifies these liabilities early in the discovery process, allowing manufacturers to adjust the product to make it safer or find an alternative.
Key aims of safety pharmacology include:
- Protection of Phase 1 clinical trial volunteers from acute adverse effects of the trial drug
- Protection of Phase 2 and 3 clinical trial volunteers and patients
- Minimizing risk of failure due to unwanted pharmacodynamic effects during drug development and marketing phases
A comprehensive safety pharmacology program helps provide the best human response prediction in the least amount of time. This more efficient process also ensures that fewer drugs are terminated before they can be optimized.
ICH Guidelines for Safety Pharmacology
The International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) “brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines”.
The ICH S7A/S7B guideline requires that a core battery of safety pharmacology studies be conducted with an experimental drug prior to human use. The ICH S7A outlines the core battery studies while ICH S7B details procedures for conducting an in vitro evaluation of delayed ventricular prolongation.
Conducting a Safety Pharmacology Study
- Study design
- The size of the subject group should be large enough to allow meaningful interpretation of data
- Appropriate negative and positive control groups
- Dose Levels
- Good laboratory practices (GLP)
- Primary pharmacodynamic studies do not need to be conducted in compliance with GLP
- Core battery studies, follow-up, and supplemental studies should be conducted in compliance with GLP
- Core battery
- Respiratory system studies – Whole-body plethysmography
- Cardiovascular system studies – In conscious or anesthetized animals; HERG and Purkinje studies (in vitro)
- Central nervous system studies – Irwin test
- Follow-up studies include central nervous, cardiovascular, and respiratory system
- Supplemental studies include renal, autonomic nervous, gastrointestinal, and other organ systems