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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

Case studies

Saila Antila, PhD

WHO consultant

Training workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence,

Kiev 3.-7.10.2005

case study 1
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

case study 13
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

case study 16
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

case study 2
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

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Case study 2

Immediate release capsule

The applicant has performed

  • one single dose study with 1 mg capsule

Case study 2

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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

case study 3
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

case study 313
Case study 3

Enteric coated capsule

  • single dose study with 2 mg capsule performed in fasting state

Case study 3

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Case study 3

Weaknesses of the documentation

  • study in fed state is missing

Case study 3

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