GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 3
Original Research
Efficient production of recombinant parathyroid hormone (rPTH) fragment 1-34 in the methylotrophic yeast Hansenula polymorpha
Author(s): et al., Frank Mueller, MSc
Page: 114-22Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background: Osteoporosis is a bone disease of the elderly that leads to increased risk of fracture. Currently, it affects more than 200 million adults worldwide, placing […]
Assessing biosimilarity using the method of generalized pivotal quantities
Author(s): et al., Shih-Ting Chiu, MSc
Page: 130-5Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability […]
Regional tenders on biosimilars in Italy: potentially competitive?
Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA
Page: 123-9Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is mainly delivered through the country’s National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of […]
