Musings on the Past 25 Years
The author cites three main areas of influence that have shaped the pharmaceutical industry into what it is today.
Reflections on Changes at FDA
A former deputy director of the Office of Pharmaceutical Sciences takes a personal look back at 25 years of change at FDA's Center for Drug Evaluation and Research.
Deliver the Dose
How will the increase in the number of new drug delivery systems affect the future popularity of the solid dosage form?
Middle-European Pharmaceutics in a Changing World
Europe's contributions to many key areas within the pharmaceutical manufacturing industry include the emergence of biopharmaceutics and chronopharmacology.
The BCS: Where Do We Go From Here?
The Biopharmaceutics Classification System, which is used to regulate the bioequivalence of oral drug products, may become an essential tool in future drug development efforts.
The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals
USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.
From Inactive Ingredients to Pharmaceutical Excipients
Developments in technology and increased industry standards have changed the regulation, quality control, and perception of excipients in the past 25 years.
Am I Going Backwards?
Natural products, modern drugs, and scientifically reproduced natural materials share space in our current pharmacopeias.
The Filter Scene: Old and New
Dynamic achievements in pharmaceutical filtration have led to significant changes in the areas of validation, integrity testing, and grow through.
Catching Up with Expert Systems
The pharmaceutical industry faces some roadblocks in terms of the implementation of expert systems. Principal among them are FDA's requirements for the submission of software codes.
25 Years of Change in the Parenteral Technology Field
Significant advances have shaped the past 25 years in the pharmaceutical industry, and the next 25 years will be no exception.
The Future State of Computer Validation, Part I
Current events and trends in regulations, business practices, and technology forecast the future of computer validation.
Statistical Thinking
An important advancement in statistics may be a new approach to implementing statistical thinking into industry processes.
2001: An Odyssey in Inhaler Formulation and Design
Recent advances in pressurized metered-dose inhalers provide an optimistic outlook for the treatment of pulmonary and systemic diseases.
What Is the "Correct" Method to Use for Particle-Size Determination?
Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.
10 Turning Points in Pharmaceutical Packaging
In the past three decades, several industry-altering episodes have changed the face of pharmaceutical packaging.
