Related Experiment Video
Updated: Jan 28, 2026

Shaping the Amplitude and Phase of Laser Beams by Using a Phase-only Spatial Light Modulator
Published on: January 28, 2019
Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies
Nadia Harbeck1, Jessie Wang2, Gordon Philipp Otto3
1Breast Center, Department of Obstetrics and Gynecology, University of Munich (LMU), Munich 81377, Germany.
Abstract:
Aim: This analysis compares safety data for Sandoz proposed biosimilar (LA-EP2006) and reference pegfilgrastim from a Phase I pharmacokinetic/pharmacodynamic study in healthy volunteers (HVs) and two Phase III confirmatory studies in patients with breast cancer (BC; total n = 808). Patients & methods: Baseline characteristics were summarized, and event rates of bone pain and headache calculated. Results: HVs in the Phase I pharmacokinetic/pharmacodynamic study were generally younger, with lower mean body mass index, versus BC patients in PROTECT-1/-2. Bone pain was the most frequent adverse event with similar incidences with reference versus proposed biosimilar in all studies. Conclusion: No differences in adverse events were found between Sandoz proposed biosimilar and reference pegfilgrastim, notwithstanding some differences between HVs and BC patients.
Related Concept Videos
Phase Diagrams
Phase Transitions
Inductance: Single-Phase And Three-Phase Line
Single-Phase Two-Wire Line:
A single-phase line consists of two solid cylindrical conductors, denoted as x and y. Each conductor carries phasor currents ix and iy, respectively. Given that the sum of these currents is...
Capacitance: Single-Phase And Three-Phase Line
Single-Phase Lines
Consider a single-phase, two-wire transmission line with equal phase spacing energized by a voltage source. One conductor carries a uniform positive charge, while the other carries an equal negative charge. The capacitance C of the line can be derived from the voltage V between the conductors. For a one-meter section of the line, the capacitance is given...
Phase Changes
A substance melts or freezes at a temperature called its melting point and boils or condenses at its boiling point. These temperatures depend on pressure. High pressure favors the denser form of the substance, so typically, high pressure...
Phase-lead and Phase-lag Controllers

