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Biopharmaceutics, If you want to determine the bigger picture of drug…

- - - - drug should target near the MSC
    - - tells you how the drug is moving inside the body
      - describes when the drug is absorbed and eliminated
      - onset time: the time reaches the MEC for the patients experience the effects
  - - - bioequivalence studies ensure the public that the generic is much as good as the innovator
- - - - how, when and where will the drug be released from the delivery system
      - consider the design of the DELIVERY SYSTEM
    - - how fast? where? how much?
      - consider the form and design of the API
    - - administration
        
        liberation
        
        dissolution
        
        convection and diffusion
        
        absorption
        
        rate-limiting step of conventional oral dosage form
        
        rate-limiting step of modified-release form
  - - - indicates the time to break down into small particle, not necessarily solution
    - - indicates the time it takes for the drug to dissolve from the dosage form
      - affected by the dissolution medium, agitation, temperature
      - in vitro surrogate for bioavailability
        
        will the drug dissolve in the body?
        
        will the drug be absorbed?
      - BCS
      - In vitro in vivo correlation
      - biowaiver
  - - - synthesis of analog
        
        you should ensure that the hit has analog just in case the hit has undesirable property
      - biological evaluation
        
        assess toxicity
      - SAR, QSAR, QSPkR
      - Chemical, Manufacturing, Control
      - what are the things to look at in the drug discovery
        
        physicochemical characteristics of the drug
        
        you look the ideal property in relation to biological systems and other substances
      - preformulation flowsheet
        
        serve as a guide on what to do next
        
        will guide you the formulation (excipients to use)
      - Pre-clinical studies
        
        clinical testing
        
        phase I
        
        bioavailability (F) is studied among the PK parameters
        
        measurement of both rate of drug absorption and total amount drug that reaches the general circulation
        
        three parameters of assessments
        
        Cmax
        
        Tmax
        
        AUC
        
        T1/2
        
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        phase II
        
        performance of clinical trial formulation
        
        formulation changes in this phases
        
        phase III
        
        formulation development for marketing
        
        NDA
        
        requirements to be submitted
        
        physicochemical characterization
        
        biopharmaceutical classifcation
        
        formulation development
        
        toxicity
        
        instability
        
        unexpected results
        
        studies
        
        absorption studies
        
        IV and oral administration
        
        whether the drug is better to be administered orally or IV
        
        formulation development
        
        BCS
        
        drug development tool
        
        based on correlation of solubility with their bioavailability in human body
        
        allows estimation of the contributions of three major factors (dissolution, solubility, and intestinal permeability) which affect drug absorption from solid products
        
        has correlation
        
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        has no correlation
        
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        low or no correlation
        
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    - - to attain an optimized formulation that ensures that the drug will reach the target site in a concentration that produces the desired therapeutic response