Pharmaceutical Technology-09-15-2019

Pharmaceutical Technology

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars.

Pharmaceutical Technology

While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.

Pharmaceutical Technology

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.

Pharmaceutical Technology

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

Pharmaceutical Technology
Pharmacopoeial Compliance Series

September 15, 2019

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Pharmaceutical Technology
Pharmacopoeial Compliance Series

September 15, 2019

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Pharmaceutical Technology
Pharmacopoeial Compliance Series

September 15, 2019

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Pharmaceutical Technology
Regulatory Resources

September 15, 2019

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Pharmaceutical Technology
Regulatory Resources

September 15, 2019

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.