ICH GUIDELINES
ICH Guidelines & GLP Regulations
- Documentation of your system from assembly to post-installation (IQ documentation).
- Validation help with SOP's for your in-house validation.
- Meets data requirements for ICHS7A guidelines for cardiovascular, respiratory, neurological, follow up and GLP studies.
- Proven quality management system.
ICHS7A Guidelines
Safety Pharmacology Studies for Human Pharmaceuticals
ITS helps you meet:
2.3.2 Use of In Vivo and In Vitro Studies
2.7 Safety Pharmacology Core Battery
2.7.1 Central Nervous System
2.7.2 Cardiovascular System
2.7.3 Respiratory System
2.8 Follow Up and Supplemental Safety Pharmacology Studies
2.8.1.1 Central Nervous Systems - EEC, EMG, ECG
2.8.1.2 Cardiovascular System - Cardiac Output, Left Ventricular Pressure
2.8.1.3 Respiratory System - PulmonaryArterial Pressure
2.8.2.1 Renal/Urinary System - Renal Blood Flow
2.8.2.2 Autonomic Nervous System - Baroreflex, Heart Rate Variability
2.8.2.3 Gastrointestinal System - Transit Time, Gut Motility
2.11 Application of Good Laboratory Practice (GLP)
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