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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All data collection, analysis and management systems are fully compliant with 21 CFR part 11 regulations.
They are designed and developed to meet the GLP requirements of CFR Title 21 Part 58.

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Last Updated: 01/26/2007 10:46 PM