Case studies l.jpg
This presentation is the property of its rightful owner.
Sponsored Links
1 / 15

Case studies PowerPoint PPT Presentation


  • 116 Views
  • Uploaded on
  • Presentation posted in: General

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

Download Presentation

Case studies

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Case studies l.jpg

Case studies

Saila Antila, PhD

WHO consultant

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

Kiev 3.-7.10.2005


Case study 1 l.jpg

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 l.jpg

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


Pharmacokinetic parameters single dose fed state l.jpg

Pharmacokinetic parameters, single dose, fed state

Case study 1


Pharmacokinetic parameters multiple dose fed state l.jpg

Pharmacokinetic parameters, multiple dose, fed state

Case study 1


Case study 16 l.jpg

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 l.jpg

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


Case study 28 l.jpg

Case study 2

Immediate release capsule

The applicant has performed

  • one single dose study with 1 mg capsule

Case study 2


Pharmacokinetic parameters single dose fasting state parent drug l.jpg

Pharmacokinetic parameters, single dose, fasting state, parent drug

Case study 2


Pharmacokinetic parameters single dose fasting state metabolite l.jpg

Pharmacokinetic parameters, single dose, fasting state, metabolite

Case study 2


Case study 211 l.jpg

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 l.jpg

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 l.jpg

Case study 3

Enteric coated capsule

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

Case study 3


Pharmacokinetic parameters single dose fasting state l.jpg

Pharmacokinetic parameters, single dose, fasting state

Case study 3


Case study 315 l.jpg

Case study 3

Weaknesses of the documentation

  • study in fed state is missing

Case study 3


  • Login