Drug Stability：药物稳定性.pptVIP

Drug Stability Outline Introduction – The Importance of Drug Stability Regulatory Aspects Degradation Pathways and Mechanisms Experimental Methods Kinetics Physical Stability Diamonds are ForeverDrugs Have A Shelf Life The Consequences of Drug Instability Loss of Active Formation of a Toxic Degradation Product Increase in the Concentration of Active Change in Bioavailability Change in Patient Acceptability Other Factors Stability Program Stages Bulk Drug and Excipients Formulation Development Drug Safety Formulations Clinical Trials Materials Marketed Product Stability Must Be Understood to Ensure The Safety of The Patient Regulatory Aspects of Drug Stability /cder/guidance “The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of experimental factors such as temperature, humidity, and light. Stability testing permits the establishment of recommended storage conditions, retest periods, and shelf lives” Three Types of Stability Testing Required in the Regulations Long Term Real Time Testing Accelerated Testing Stress Testing/Forced Degradations Long Term Real Time Testing Proof of Expiration Dating and Storage Conditions “Stability evaluation of the physical, chemical, biological, and microbiological characteristics of a drug substance and a drug product, covering the expected duration of the shelf life and retest period, which are claimed in the submission and will appear on the labeling.” Accelerated Testing “Studies designed to increase the rate of chemical degradation or physical change of an active drug substance and drug product by using exaggerated storage conditions as part of the formal definitive stability protocol. These data, in addition to long term stability data, may also be used to assess longer term chemical effects at non-accelerated conditions and to evaluate the impact of short term excursions outside the label storage conditions