ABSTRACT
OBJECTIVE: To lay a basis on constructing theory and method of the pharmaceutical evaluation.METHODS: By synthesizing the literature and experience,the authors summarized and explained the pharmaceutical evaluation factors which included rationality of preparations,quality controllability,and delivery efficacy etc.RESULTS: The factors of rationality of preparations included the choice of dosage form,specification and package amount;the factors of quality controllability included active constituent,foreign matter,package and stability,and the factors of delivery efficacy included dissolution or releasing degree and device packaging,CONCLUSION: This system of evaluation factors is systematic,dynamic and practical.
ABSTRACT
OBJECTIVE: To establish the theory and method for the analysis of systematic hypothesis on adverse drugs events. METHODS: System of causal analysis of adverse drug events and analytical methods on systematic hypothesis were established by applying systematical and scientific thoughts; and the application of which in the quality analysis of oral solid preparations and injections were explained. RESULTS: The system of causal analysis consists of subsystems of drug standard deficits, problems of drugs quality, adverse drugs reactions, medication errors and drug abuse subsystems. The analysis on systematic hypothesis consisted of 4 steps: producing signal, raising the hypothesis, demonstrating, and drawing the conclusions. CONCLUSION: The causal analysis system of adverse drug events and analytical methods on systematic hypothesis combined not only reductionism with holism but also analysis with synthesis, which can help to solve the complicated matter in clinical medication.