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Pharmaceutical Supply Chain Gradually Working Toward Data Interoperability for DSCSA
Monday, May 16, 2022

Progress toward the 2023 Drug Supply Chain Security Act (DSCSA) requirement for full product serialization is uneven, with some progress and obstacles... read more
Pharmaceutical Supply Chain Security Risk Assessment for Shipping Lanes
Sunday, September 24, 2017

Abbvie, Eli Lilly and Company, Sensitech Inc, TEVA Pharmaceutical Industries Ltd., MSD, McKesson Canada, GSK, Purdue Pharma Technologies Inc

With the publication of the European GDP guideline, to better protect the pharmaceutical supply chain all actors in the pharmaceutical supply chain ... read more
Pharmacokinetic and Statistical Considerations in First-in-Human Clinical Trials
Friday, May 31, 2019

One of the major challenges when undertaking a first-in-human (FIH) clinical trial is how to appropriately plan and analyze the pharmacokinetics (PK) ... read more
Pharmacovigilance in Australia and New Zealand
Monday, March 01, 2010

Drug safety in Australia is regulated via the Office of Medicines Safety Monitoring (OMSM) (synonymous with Adverse Drug Reaction Advisory Committee),... read more
Pharmacovigilance in the Age of the Specialty Pharmacy
Wednesday, September 30, 2015

It began with a notion. Concentrating the flow of specialized medicines through distinct channels maximized not only to the patient’s care but also ... read more
Phase Change Materials, A Brief Comparison of Ice Packs, Salts, Paraffins, and Vegetable-derived Phase Change Materials
Friday, July 01, 2011

Passive processes for thermal energy storage have received a lot of attention in the past 25 years. These passive thermal energy storage materials ... read more
Phase-Appropriate Frameworks at the Intersection of CMC and cGMP Pathways
Friday, June 30, 2017

Pharmatech Associates

Pressure and scrutiny from regulators, customers, and stakeholders continue to drive the pharmaceutical industry to search for alternate ways to ... read more
Planning for Success in Early Phase Clinical Trials
Thursday, September 24, 2020

SGS Life Science Services

Early phase clinical trials are becoming increasingly complex, potentially leading to a higher risk of failure. But careful planning and attention to ... read more
Plastic Pre-fillable Syringes and Vials: Progress Towards a Wider Acceptance
Friday, January 01, 2010

A number of trends can be identified in the delivery of parenteral drugs in the last decade. read more
Play Silly Games, Win Silly Prizes
Sunday, December 01, 2024

It started innocently enough. A nudge in the middle of the night from my wife to roll over because I was snoring. But over time it escalated. From a ... read more
Points to Consider in Filing Data for Shipment of Temperature Controlled Drug Substances/Products
Monday, November 30, 2015

Abbvie, Eli Lilly and Company, Merck

Twenty years ago, the risk to drug substance/product quality due to temperature excursions during shipping was not generally appreciated. A series ... read more
Potential Contribution of a Plasticized PVC Packaging Material to the Level of Elemental Impurities in Packaged Drug Products
Thursday, March 26, 2015

Extraneous impurities in a drug product do not provide a therapeutic benefit to the product’s user and could adversely impact the safety and/or ... read more
Practical Approaches in Applying Process Analytical Technology (PAT) Tools to Early Active Pharmaceutical Ingredient (API) Development
Friday, July 01, 2011

The amount of time required to successfully develop a new drug candidate from discovery to commercialization is estimated to be 12-15 years and the ... read more
Pre-Filled Syringes: Development Challenges and the Value of Partnership
Tuesday, September 08, 2020

AMRI

In this article, we will chart the rise of the PFS, outline some common challenges, and explain how partnership is the only route to success. read more
Preclinical Roundtable
Friday, July 01, 2011

From my perspective, it appears many companies are paying more attention to value or getting the most service for invested dollars read more