Authors
Latest:
Drug Development Application HandbookWelcome to Pharmaceutical Technology’s Drug Development Application Handbook, a compilation of technical articles from the magazine’s archives and application notes, technical information, and educational materials from the handbook’s sponsors. In this ebook, you will find insight and guidance on quality risk management, highly potent APIs, quality by design for API development, aseptic processing, tablet manufacturing, equipment, and more. We hope this information is useful in supporting your drug development and manufacturing operations.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
Cleaning of Dedicated Equipment: Why Validation is NeededThis article discusses cleaning validation of equipment dedicated to the production of a single API.
Latest:
A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
Latest:
A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
Latest:
A Risk-Based Approach to Data IntegrityHeightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information.
Latest:
Labs on the Frontlines: Balancing Re-Entry and the Race to a COVID-19 CureHow real estate can accelerate productivity as life sciences companies prioritize COVID-19 therapeutics, vaccines, and new diagnostics R&D amidst new guidelines.
Latest:
Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
Latest:
Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
Latest:
Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug DeliveryDelivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.
Latest:
Environmental Containment Performance—Is There Accountability?Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
Latest:
Environmental Containment Performance—Is There Accountability?Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
Latest:
Managing Clinical Development Risk: Pharma and CRO ReportThe relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
Latest:
Are IPRs Impacting the Pharmaceutical Industry?As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.
Latest:
Requirements for Product Technology TransferSusan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
Latest:
PAT Paves the Way for Continuous ManufacturingProcess analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
Latest:
PAT Paves the Way for Continuous ManufacturingProcess analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.
Latest:
Controlled Release from Porous PlatformsThe authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
Latest:
Surface Neutralization SystemA new, robust method for protein elution from ceramic hydroxyapatite.
Latest:
Piloting Track-and-Trace ImplementationVirtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
Latest:
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
