PharmTech
Nov 8, 2024 · Pharmaceutical Technology is the independent source for information, insight, and analysis on bio/pharmaceutical formulation, development, and manufacturing.
Pharmaceutical Technology Europe - PharmTech
© 2024 MJH Life Sciences ™ and . Pharmaceutical Technology. All rights reserved.
Peer Exchange
© 2024 MJH Life Sciences ™ and . Pharmaceutical Technology. All rights reserved.
GE Healthcare Life Sciences is Now Cytiva - PharmTech
Apr 1, 2020 · The company said it will continue to research collaborations, such as the center for advanced biological innovation and manufacturing in Boston with Harvard, MIT, teaching hospitals, and industry partners Fujifilm Diosynth Biotechnologies, and …
FDA Releases Compounding Guidance - PharmTech
In December 2023, FDA released two guidance documents on drug compounding using bulk drug substances. FDA provides a list of bulk drug substances that can be used in compounding, and the documents provide the agency’s interim policy for use of bulk drug substances in compounding by facilities that are considered outsourcing facilities under section 503B of the Federal Food, Drug, and ...
IVPT Data Analysis with FDA Statistical Approach to Assess
Jun 3, 2022 · This article describes the data processing procedures used by the authors from in-vitro permeation test (IVPT) studies. The article also discusses FDA statistical mathematics of evaluating a generic topical drug product, specifically acyclovir cream, against its …
EU Makes First-in-World Approval of Dupixent as Targeted
Jul 8, 2024 · Sanofi announced on July 3, 2024 that the European Medicines Agency (EMA) gave its approval to Dupixent (dupilumab), a human monoclonal antibody approved for numerous indications in more than 60 countries, for additional, maintenance treatment of adults with uncontrolled chronic obstructive pulmonary disease (COPD) (1).
Addressing the Key Pitfalls Hindering Technology Transfer Success
Nov 2, 2022 · Preliminary review and assessment by the receiving site of all documents related to the prior knowledge relevant to the development project. This will include analytical and process development reports, method and process criticality analyses, preliminary or ongoing stability data, compatibility studies, and qualification documentation, all of which are vital to …
Why Training Matters - PharmTech
Dec 2, 2015 · Facilitating compliance Formal training programmes that are well-documented help maintain compliance with regulatory requirements. As all employees performing certain functions must be qualified, quality assurance can monitor the qualification status of employees and easily demonstrate during an audit what workers were trained in what subject, and on what date.
Establishing Systems Suitability and Validity Criteria for Analytical ...
Feb 1, 2022 · A bioassay also has a requirement to be linear in the dose response.The Linearity Ratio method of analysis uses a measure of curvature relative to the linear line rather than a measure of probability by comparing the effect size attributed to the quadratic term (curve) to the effect size attributed to the linear term in the full model.In practical terms, the question of …