Background The EGFR T790M mutation is the most common mechanism of drug resistance
to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in patients who have …

Accurate prediction of the in vivo biopharmaceutical performance of oral drug formulations
is critical to efficient drug development. Traditionally, in vitro evaluation of oral drug …

Quality by design (QbD) has recently been introduced in pharmaceutical product development
in a regulatory context and the process of implementing such concepts in the drug …

Many new chemical entities are poorly soluble, requiring the use of co-solvents or excipients
to produce suitable intravenous formulations for early pre-clinical development studies. …

Purpose Osimertinib (AZD9291) 80 mg once daily is approved by the US FDA for the treatment
of patients with metastatic EGFR T790M-positive NSCLC whose disease has previously …

In recent years mechanical systems have been developed that more closely mimic the full
dynamic, physical and biochemical complexity of the GI Tract. The development of these …

Preclinical and clinical studies were conducted to determine the metabolism and pharmacokinetics
of osimertinib and key metabolites AZ5104 and AZ7550. Osimertinib was designed …

The in vivo performance of self-nanoemulsifying drug delivery systems (SNEDDSs) with
different in vitro physicochemical properties were determined with the purpose of elucidating the …

PURPOSE: To describe a novel method for calculating intraocular lens (IOL) power after
myopic laser in situ keratomileusis (LASIK) without using the inaccuracies of the post-LASIK …

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development
and performance by using therapy‐driven target drug delivery profiles as a framework …