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The Rheology of Pharmaceutical Products
Physical tests for rheological behavior are performed by R&D scientists who qualify new formulations for processability in manufacturing and acceptability to customers when consumed. Rheology is the science of flow behavior and applies to a broad range of materials, ranging across powders, liquids, soft solids (E.g. ointments), and solids (E.g. tablets, hard shell capsules). Instruments used to conduct these tests include viscometers, rheometers, texture analyzers, and powder flow testers. QC has responsibility to implement “short” versions of these tests to verify that product with consistently acceptable quality is manufactured on a daily basis.


Influence of Gut Microbiota on Drug Metabolism
Drug metabolism is a central area of research for effective drug design and therapy. What has been well explored is the metabolism of drugs after they enter the body following oral absorption. The main organ for systemic metabolism of drugs is the liver which metabolizes drugs into more hydrophilic metabolites to be excreted mainly with the urine. Other drugs and their metabolites may be excreted with the feces or via other pathways. However, what has just recently gained interest is the presystemic metabolism of drugs by bacteria in the intestinal tract. Since nearly 85% of all drugs on the market are given via the oral route, consideration of what happens to the drug after it is released from its dosage form is an important part of providing patients with the best possible therapy depending on their condition and health status. This podcast will explore the various influences that the gut microbiome may have on the metabolism of drugs. This in turn may influence the way drugs are designed and formulated to achieve the best therapeutic outcome for patients.


The Importance of Possessing Good Polymer Chemistry Knowledge in Conducting Extractables/Leachables Studies
Extractables and Leachables studies are an important part of the development cycle of any new drug product. It is important that an appropriate packaging system is chosen such that the product is stable and protected from degradation. It is equally important that this packaging system does not affect the purity of the product by leaching chemicals into the product. Rigorous extractables and leachables testing can ensure the proper packaging system is chosen, and an integral part of this testing regiment includes an extensive knowledge polymer chemistry. Davie Love answers a few short questions to help you better understand the capabilities of your vendor.


Do you really know your relative humidity calibration vendor?
There are so many ways to incorrectly calibrate a relative humidity sensor that it is important to closely look at the capabilities of your calibration vendor. ISO17025 accreditation is a very good place to start, but not all ISO17025 calibration labs are equal. David Love answers a few short questions to help you better understand the capabilities of your vendor.


Realizing Opportunities in Caregiver-intensive Settings through Transdermal Drug Delivery
In this episode, Dr. Kirsty Gapp, Transdermal Drug Delivery Platform Business Manager, EMEA, at 3M Drug Delivery Systems discusses how an aging global population and the need for continual innovation in the pharmaceutical industry factor into drug delivery systems that move beyond traditional pills and capsules into transdermal drug delivery.


Sartobind Membrane Adsorbers
Sartobind membrane adsorbers are an expedient and effective option for chromatographic removal of contaminants from a process feed stream. Built on a membrane of regenerated cellulose, Sartobind is available in strong anion and cation , hydrophobic interaction and salt tolerant anion exchange versions.


Inhalation Drug Delivery
The practice of using inhaled substances to treat medical conditions has been around for millennia. Only in the last hundred years, though, have advancements in technology have allowed inhalation drug delivery systems to become an important delivery method for pharmaceuticals used by millions of patients worldwide. In this interview, Richard Beesley from 3M Drug Delivery Systems provides an overview of the factors that have shaped inhalation drug delivery and considers how we may best equip ourselves to manage change in the future.


Basic Training: Glycan Analysis
In the Basic Training series, experts from the National Institute for Bioprocess Research and Training (NIBRT) provide in-depth looks at key bioprocessing steps. Here, Pauline Rudd discusses glycan analysis.


Establishing a Culture of Compliance
Ron Johnson, President of Becker & Associates Consulting, an NSF International Company, discusses the critical need for establishing a “culture of compliance” for companies seeking to prevent, or remediate, regulatory compliance violations. An organization’s culture is shaped by its values, principles and beliefs. These are established at the top of the organization and must be effectively communicated throughout the enterprise. Training of employees and management is one of several critical elements to the establishment of a culture of quality.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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