Dissolution research started to develop about 100 years ago as a field of physical chemistry
and since then important progress has been made. However, explicit interest in drug related …

Literature and experimental data relevant to the decision to allow a waiver of in vivo
bioequivalence (BE) testing for the approval of immediate‐release (IR) solid oral dosage …

Abstract The Biopharmaceutics Classification System (BCS) has found widespread utility in
drug discovery, product development and drug product regulatory sciences. The …

When the patent of a small molecule drug expires generics may be introduced. They are
considered therapeutically equivalent once pharmaceutical equivalence (ie identical active …

Poor aqueous solubility and dissolution of drug candidates drive key decisions on lead
series optimization during drug discovery, on formulation optimization, and clinical studies …

ABSTRACT The FDA Biopharmaceutical Classification System guidance allows waivers for
in vivo bioavailability and bioequivalence studies for immediate‐release solid oral dosage …

Cancer remains a major health problem worldwide, with colorectal cancer (CRC) being the
third most incident and the second most lethal. Inflammation, on the other hand, has been …

As the generic pharmaceutical industry continues to grow and thrive, so does the need to
conduct efficient and successful bioequivalence studies. In recent years, there have been …

Dasatinib monohydrate indicated for the treatment of chronic myeloid leukemia displays pH-
dependent solubility. The aim of reported development program of novel dasatinib …

Durch die jüngste Änderung der Approbationsordnung für Apotheker hat die Bedeutung der
Biopharmazie in Forschung und Lehre weiter zugenommen. In diesem vollständig neu …