Browse Solutions: Clinical Trials/Pilot Plant
- White Papers/Case Studies (79)
- Analyst Reports (0)
- Webcasts (0)
- Multimedia (0)
- Application Notes (7)
- Product Information (27)
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WHAT'S NEW
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PAT and TOC Analysis With an Onboard Automated Standards Introduction System ...
by Hach Ultra
White paper
<P>This paper describes the use of an on-board automated sample introduction system (OASIS) that is used to run verification standards and system suitability tests in order to ensure the reliability of the TOC results. </P>
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Comparison of TOC Analyzers and Sensors for Pharmaceutical TOC Applications
by GE Analytical Instruments
Application note
In 2006, Jon S. Kauffman, PhD., Lancaster Laboratories, published results from a study on the recovery of organic compounds likely to be present in pharmaceutical water systems using on-line TOC analyzers designed for pharmaceutical use. A new study repeats the same injections, but adds the new CheckPoint TOC Sensor from GE Analytical Instruments.
REPORTS BY TOPIC
Phase II-IV Clinical Trials Services
By AAI Pharma Inc.
Product collateral
AAIPharma's Phase II-IV Clinical Trials services offers highly qualified clinical research teams including project managers, physicians and scientists, clinical research associates (CRAs), biostatisticians, data managers, medical writers, quality and regulatory specialists, working relationships with a network of study sites around the world, and eClinical technologies to assure critical path...
Integrating good manufacturing practices during the transition from clinical ...
By Ross Systems Inc.
White paper
According to this white paper by Ross Systems Inc., early adoption of good manufacturing practice (GMP) can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, whether in house or outsourced.
Phase I-IIA Clinical Pharmacology Services
By AAI Pharma Inc.
Product collateral
AAIPharma's Phase I-IIA Clinical Pharmacology services offer experienced research teams of physicians, nurses, technicians and CRAs, rapid subject recruitment, healthy volunteers as well as special populations, a focus on volunteer and patient safety, regulatory compliance, and strict adherence to the protocol.
Helping cancer patients take their medicine
By Microfluidics Corp.
Case study
In this case study, a cancer treatment drug being tested in a trial at Johns Hopkins Oncology Center is delivered intravenously — with far fewer side effects for patients — with help from Microfluidics Corp.'s Microfluidizer processor.
Instantaneous Microbial Detection
By BioVigilant Systems Inc.
White paper
This white paper by BioVigilant Systems Inc. discusses its optical technology, which can determine the quantity and size of particles in liquid or air and whether each particle is inert or biologic, resulting in instantaneous and continuous microbial detection.
Fault tolerance is the missing ingredient in the pharma drive for process ...
By Stratus Technologies
White paper
This white paper by Stratus Technologies outlines the pharma industry's need for fault-tolerant computing, based on growing needs for electronic batch record (EBR) and process analytical technology (PAT) information systems.
EU Clinical Trials Directive: Effects on clinical research
By Fulcrum Pharma Developments
White paper
Fulcrum Pharma Developments Inc. outlines the main objectives of the European Union (EU) Clinical Trials Directive and reviews how to respond so that clinical trials can be performed in the most cost-and time-effective manner.
Key tests for breakthrough blood safety system
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services performs viral validations for Navigant Biotechnologies that help the company perfect the system, obtain Food and Drug Administration approval and move the product to market.
Are you ready for an FDA inspection?
By MasterControl Inc.
White paper
This white paper by MasterControl Inc. describes how it went about becoming compliant with Food and Drug Administration standards, the difficulties involved and how companies can go through the same process.
Phase I-IIA Clinical Pharmacology Services
By AAI Pharma Inc.
Product collateral
AAIPharma's Phase I-IIA Clinical Pharmacology services offer experienced research teams of physicians, nurses, technicians and CRAs, rapid subject recruitment, healthy volunteers as well as special populations, a focus on volunteer and patient safety, regulatory compliance, and strict adherence to the protocol.
PAT and data availability
By Aegis Analytical Corp.
Application note
In this application note, Aegis Analytical Corp. describes how process analytical technology (PAT) addresses data availability issues in process manufacturing and outlines how PAT helps the U.S. Food and Drug Administration (FDA) achieve significant improvements in pharma compliance and performance.
FDA Guidance for Industry: Gene Therapy Clinical Trials
White paper
This guidance provides sponsors of gene therapy studies, recommendations regarding the design of studies to include the collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products.
Solvent-Free Pilot and Process Scale Super Critical Fluid Extraction (SFE) ...
By Thar Technologies
Product collateral
Because pilot scale requirements vary greatly from application to application, Thar emphasizes flexibility and cost effectiveness in the design and development of its systems.
Integrating good manufacturing practices during the transition from clinical ...
By Ross Systems Inc.
White paper
According to this white paper by Ross Systems Inc., early adoption of good manufacturing practice (GMP) can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, whether in house or outsourced.
ClinPhone Drug Accountability
Product collateral
Together with ClinPhone’s automated Trial Supply Management services, ClinPhone Drug Accountability enables management of the entire clinical supply chain.
Why Do you Need to be Concerned About Global Hazard Communications?
By American Industrial Hygiene Assn.
White paper
This white paper from the American Industrial Hygiene Association states that if material data safety sheets (MSDSs) are to remain a valuable tool in the protection of workers and others, all industrialized countries must work together to see that they contain the most reliable and accurate data available.
Clean-in-Place Operations for Thin-Cake Filtration Technologies
By BHS-Filtration Inc.
White paper
This white paper from BHS-Filtration Inc. discusses the choice of thin-cake separation technologies and their benefits to optimizing the effectiveness of the production process, and discusses clean-in-place (CIP) operations to meet current Good Manufacturing Practice (cGMP) guidelines.
Honeywell Capitalizes on Plant Knowledge and a Life Cycle of Value
By Aberdeen Group
White paper
In this white paper by Aberdeen Group Inc., Honeywell Process Solutions (HPS), a global solution provider of process control systems, software and related services, is evaluated. HPS's solutions are worthy of review by pharmaceutical manufacturers because plant and business systems are linked while mission-critical applications are kept up and running.
