Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability

Gordon L. Amidon, Hans Lennernäs, Vinod P. Shah et al. · Pharmaceutical Research · 1995 · 5.3K citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +16

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

Lawrence X. Yu, Gordon L. Amidon, James E. Polli et al. · Pharmaceutical Research · 2002 · 565 citations · Full text

Pharmacy, Pharmacokinetics, Pharmacology +11

Accelerated aging: Prediction of chemical stability of pharmaceuticals

Kenneth C. Waterman, Roger Adami · International Journal of Pharmaceutics · 2005 · 373 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutics +10

Methods to Compare Dissolution Profiles and a Rationale for Wide Dissolution Specifications for Metoprolol Tartrate tablets†

James E. Polli, Gurvinder Singh Rekhi, Larry L. Augsburger et al. · Journal of Pharmaceutical Sciences · 1997 · 333 citations

Pharmacy, Pharmaceutics, Pharmacology +16

Oral Absorption of Poorly Water-Soluble Drugs: Computer Simulation of Fraction Absorbed in Humans from a Miniscale Dissolution Test

Ryusuke Takano, Kiyohiko Sugano, Atsuko Higashida et al. · Pharmaceutical Research · 2006 · 277 citations

Pharmacy, Pharmaceutics, Pharmacokinetics +17