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Case studies

Case studies. Saila Antila, PhD WHO consultant Training workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence, Kiev 3.-7.10.2005. Case study 1. Characteristics of drug X half-life, conventional preparations: 4-6 h

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Case studies

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  1. Case studies Saila Antila, PhD WHO consultant Training workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence, Kiev 3.-7.10.2005

  2. Case study 1 Characteristics of drug X • half-life, conventional preparations: 4-6 h • half-life from modified release preparations: 11-15 hours • food decreases absorption of the drug • innovator’s SPC: steady state concentrations are reached by the fourth day of the treatment Case study 1

  3. Case study 1 Modified release tablet The applicant has performed • single dose, randomised, 2-period, cross-over study in fed state • multiple dose, randomised, 2-period, cross-over study in fed state • first treatment period 4 days • second treatment period 3 days Case study 1

  4. Pharmacokinetic parameters, single dose, fed state Case study 1

  5. Pharmacokinetic parameters, multiple dose, fed state Case study 1

  6. Case study 1 Weaknesses of the documentation • study in fasting state is missing • the second treatment period is too short according to the originators SPC steady state is achieved by the fourth treatment day Case study 1

  7. Case study 2 Characteristics of drug Y • active metabolite • R- & S-enantiomers • linear pharmacokinetics • multiple strengths (0.5, 1 mg, 2 mg, 4 mg) • antipsychotic agent Case study 2

  8. Case study 2 Immediate release capsule The applicant has performed • one single dose study with 1 mg capsule Case study 2

  9. Pharmacokinetic parameters, single dose, fasting state, parent drug Case study 2

  10. Pharmacokinetic parameters, single dose, fasting state, metabolite Case study 2

  11. Case study 2 • for safety reasons single dose study with 1 mg is accepted • since linear pharmacokinetics, enantiospecific methods are not needed Case study 2

  12. Case study 3 Characteristics of drug Z • bioavailability 80-90 % • linear pharmacokinetics at doses 0.25-10 mg • multiple strengths (1 mg and 2 mg) Case study 3

  13. Case study 3 Enteric coated capsule • single dose study with 2 mg capsule performed in fasting state Case study 3

  14. Pharmacokinetic parameters, single dose, fasting state Case study 3

  15. Case study 3 Weaknesses of the documentation • study in fed state is missing Case study 3

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