The Growing Regulatory Burden and Revolution in Global Clinical Trials

Article

Special Issues

LCGC SupplementsSpecial Issues-07-01-2006
Volume 0
Issue 0

At the same time the pharmaceutical industry faces new and complex issues with the drug development process and clinical trial environment, regulatory policies are increasing and adding to the burden of cost and time to market.

External Link - article-416303.pdf

Articles in this issue
Analytical Instrument Qualification
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
GMP and Phase I Clinical Trials: Streamlining the Critical Path?
Team Effort
Team Effort
Rated PG: Pharmaceutical Guidance Suggested
Rated PG: Pharmaceutical Guidance Suggested
European Clinical Trial Regulations Undergo a Slow Revolution
European Clinical Trial Regulations Undergo a Slow Revolution
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
A Practical and Cost-Effective Risk Assessment for the Validation of Commercial Laboratory Computerized Systems
Moving Biotech Products from CBER to CDER: A Work in Progress
Moving Biotech Products from CBER to CDER: A Work in Progress
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chief
New Climate
New Climate
2006: A Regulatory Odyssey
2006: A Regulatory Odyssey
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
CDER?s Division of Post-Marketing Evaluation for Quality Assessment
Better Compliance Through Technology
Better Compliance Through Technology
Good Clinical Practice Q&A
Good Clinical Practice Q&A
Keeping Pace
Keeping Pace
The Growing Regulatory Burden and Revolution in Global Clinical Trials
The Growing Regulatory Burden and Revolution in Global Clinical Trials
Recent Videos
Related Content
Modern Medical Research Laboratory: Two Scientists Working, Using Digital Tablet, Analyzing Test, Talking. Advanced Scientific Pharmaceutical Lab for Medicine, Biotechnology Development. Evening Time | Image Credit: © Gorodenkoff - stock.adobe.com

Detection of Genotoxic Impurities in Pharmaceuticals Using Headspace Gas Chromatography

Kate Jones
January 14th 2025
Article

A method to help detect genotoxic impurities (GTIs) using headspace gas chromatography (HS-GC) and deep eutectic solvents (DESs) has been developed.

Analyzing New Drug Modalities: An ISC 2024 Interview with Kelly Zhang

Analyzing New Drug Modalities: An ISC 2024 Interview with Kelly Zhang

Alasdair Matheson
January 10th 2025
Article

At ISC 2024 in Liverpool, United Kingdom, LCGC International interviewed Kelly Zhang of Genentech about her work analyzing new drug modalities, such as mRNA, oligonucleotides, peptides, and cell and gene therapies.

Separation Science Worldwide: A Year of Conferences with LCGC

Separation Science Worldwide: A Year of Conferences with LCGC

Aaron Acevedo
December 27th 2024
Article

Throughout 2024, the editors of LCGC International attended chromatography conferences across the globe. Below, you’ll find a sampling and overview of our conference coverage from the year.

Assorted pharmaceutical medicine pills, tablets and capsules.Pills background: © klepach - stock.adobe.com

HILIC-SPE and LC–HRMS Method Used for N-Nitrosamine Detection in Pharmaceuticals

Kate Jones
December 23rd 2024
Article

An LC–HRMS approach for the simultaneous analysis of 15 N-nitrosamines in multiple APIs using a novel HILIC-based SPE clean-up step has been developed and tested.

Best of the Week: Investigating Volatiles in Food Packaging, The Future of Digital Method Development, and More

Best of the Week: Investigating Volatiles in Food Packaging, The Future of Digital Method Development, and More

Aaron Acevedo
December 13th 2024
Article

Here is some of the most popular content posted on LCGC International this week.

Abstract background with molecules. Generated with AI. | Image Credit: © Sanook - stock.adobe.com

Analytical Method Lifecyle of SFC Methods from Development Use to Routine QC Implementation: Supporting Small Molecule R&D and Commercialization

Claudio Brunelli;Wayne Callar
December 12th 2024
Article

In this article, we review some key considerations for chromatographic technique selection and method development across the full drug process—from early-stage active pharmaceutical ingredient (API) synthesis to routine commercial release activities.