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ICH Guidelines
 

ICH Guidelines and GLP Regulations

  • Documentation of your system from assembly to post-installation (IQ documentation)
  • Validation help book with list of SOPs for your in-house validation
  • 21 CFR, Part 11 user requirements throughout the system
  • Meets data analysis and requirements for ICHS7A guidelines for cardiovascular, respiratory, neurological, follow up, and GLP studies
  • Proven quality management system with proven Software Development Life Cycle

ICH S7A Guidelines

Safety Pharmacology Studies for Human Pharmaceuticals
DISS 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 - Pulmonary Arterial 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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