Safety Pharmacology

GLP hERG

• We provide hERG studies under GLP GLP:
  In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) safety and efficacy tests. The test results generated in accordance with GLP principles in an OECD member country are accepted in other member countries. An internationally recognized definition of GLP is provided by the Medicines and Healthcare products Regulatory Agency UK:
  
  Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments ) conditons!
• Please contact us directly to initiate your GLP hERG study
• Our standard GLP hERG IC₅₀ determination comprises cumulative application of four test concentrations on one cell with three replicates.

Study execution:
Prior to the experimental start of the study, a draft GLP Study Plan is provided to the customer. Upon customer’s consent and review by our Quality Assurance Unit, the Final Study Plan is signed by both the customer and the testing facility.

The experimental study is performed according to SOPs (Standard Operating Procedures) and controlled by the Quality Assurance Unit. Results are summarized by the Study Director in a draft GLP Study Report reviewed by the customer and the Quality Assurance Unit. Upon consent the Final Study Report is compiled by the Study Director and sent to the customer.

GLP Study Records and the Final Study Report are archived for 15 years.

A first Study Report draft is available to our client in one week after experimental starting date!