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Bioavailability & Bioequivalence Pharmacokinetic Principles

Sandip K. Roy, Ph.D.
Exploratory Clinical Development PK
Novartis Pharmaceutical Corporation


Pharmacokinetics is either directly or indirectly associated with just about every part of pharmaceutical business:

Research and the selection of a promising molecule
Dosage formulation development
Dose regimen
Toxicology and safety assessment
Dosing recommendations for age groups & sub-populations (renal/hepatic/race/DDI)
Effect of meals and dosing
Marketing claims and promotion
Generic substitution
Manufacturing changes