Bioequivalence and Bioavailability Forum

Hi MGR & Pin!

I think that it mainly depends how far Pin wants to go with ‘analyze pharmacokinetic’.

❝ I suggest R, Kinetica, Nonmem.

NONMEM? Wow!

• R
  Free. Steep learning curve.
  Packages:
  bear: NCA (SD, MD) & BE (2×2 cross-over, parallel, conventional replicate designs = no scaling according to latest FDA/EMA code).
  See also category R for BE/BA of the forum.
  PK: Basic NCA; only linear trapezoidal rule covered
  PKfit: Model/curve fitting simulations
  PKtools for WinBUGS/PKBUGS: Bayesian PopPK; single dose only
  ivivc (sic!)
  
• Kinetica
  ? first buy, 800 USD annual. The user interface is terrible. IMHO makes only sense if you have other software (CDS, LIMS) from Thermo already installed – system integration easy.
  Pro: Population PK and IVIVC included. Once you have mastered the GUI use is straightforward.
  Con: No BE for higher order cross-overs, no replicate designs. Some bugs (like this one unresolved for 10+ years). Support’s responsiveness close to nil.
  
• NONMEM
  5,150 USD annual for 4 processor cores (if you have a modern CPU: 4,120 USD for each additional 4 cores).
  PLT Tools (Graphical interface): 4,000 USD, 2,000 USD annual
  Very (!) step learning curve. You need additional software to perform comparative statistics.
  
• Phoenix/WinNonlin
  ? first buy, 1,726 USD annual.

Conclusion: If you want to cover NCA and all methods needed for BE (parallel, X-overs, replicates) only R is a cost-saving alternative.