Rethinking Clinical Trials and Personalized Medicine with Placebogenomics and Placebo Dose.

Pharmacogenomics, nutrigenomics, vaccinomics, and the nascent field of plant omics are examples of variability science. They are embedded within an overarching framework of personalized medicine. Across these public health specialties, the significance and biology of the placebo response have been historically neglected.

Digging Deeper into Precision/Personalized Medicine: Cracking the Sugar Code, the Third Alphabet of Life, and Sociomateriality of the Cell.

Precision/personalized medicine is a hot topic in health care. Often presented with the motto "the right drug, for the right patient, at the right dose, and the right time," precision medicine is a theory for rational therapeutics as well as practice to individualize health interventions (e.g.

A New Approach to Measure Adherence to Medicines Using Biomarkers and Sensors.

Approximately one in two patients with a chronic disease does not take their medicines as prescribed. Poor adherence is a worldwide epidemic and a major source of variability in pharmacokinetics (PK) and pharmacodynamics. Without addressing adherence, precision medicine is unlikely to come to fruition.

Interchangeability Of Biological Drug Products-FDA Draft Guidance.

The Biological Price Competition and Innovation Act (BPCI Act) of 2009 established a pathway for the approval of biosimilars and interchangeable biosimilars in the United States. The Food Drug Administration (FDA) has issued several guidances on the development and assessment of biosimilars which implement the BPCI Act. In particular, a recent draft guidance on the interchangeability of biological products presents an overview of scientific considerations on the demonstration of interchangeability with a reference product.

Panos Macheras: a pioneering scientist in pharmaceutical science.

Professor Panos Macheras is a pioneering scientist in pharmacokinetics, pharmacodynamics and biopharmaceutics. His many important contributions to pharmaceutical science are reviewed.