INSIGHTS ON DRUG DEVELOPMENT
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![scientist laboratory research iStock-942266140]( "Continued Performance Verification Of Analytical Procedures Using Chromatography Data Software")
Continued Performance Verification Of Analytical Procedures Using Chromatography Data SoftwareContinued performance verification of the analytical procedure lifecycle approach routinely examines performance data of a method over its lifecycle. This paper explores how to facilitate the continued procedure performance verification stage of the analytical procedure lifecycle approach.
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![Gears workflow process management]( "The Method Detectives: Building A New Business Model With Analytical Procedure (Method) Lifecycle Management")
The Method Detectives: Building A New Business Model With Analytical Procedure (Method) Lifecycle ManagementUsing a toolbox of instrumentation, chemistries, and software, an innovative pharmaceutical services provider solves customers’ challenges with method development and validation.
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![iStock-1293772875-lab-research-scientist-microscope]( "Oral Controlled Delivery Of Poorly Water-Soluble Drugs")
Oral Controlled Delivery Of Poorly Water-Soluble DrugsVarious drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.
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![iStock-842481112-child-medicine-tablet-capsule]( "Age-Appropriate Pediatric Formulation Development")
Age-Appropriate Pediatric Formulation DevelopmentThere is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.
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Formulation Development Strategy For Early Phase Human Studies1/27/2022
Determination of an appropriate bioavailable formulation for animal PK, GLP toxicity, first-in-human and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
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R&D And Analytic For Early Stage Development1/27/2022
Pii’s extensive experience in understanding different analytical requirements allows us to better serve our partners’ needs. And we are proud to offer several of these capabilities in house.
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Rational Design Of Oral Nanosuspensions For Insoluble Drugs1/26/2022
The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.
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Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway1/26/2022
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
DRUG DEVELOPMENT SOLUTIONS
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Improve productivity and cell growth in fed-batch cultures by supplementing the cell culture medium to boost nutrients depleted during culture. HyClone™ Cell Boost™ 2 Supplement provides nutrients such as amino acids and glucose that are suitable for research and bioprocessing applications.
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Optimize your small molecule API, and de-risk your product development. Understanding the physical characteristics of API and required modification is critical to successful product development and product performance.
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![Drug Development: Strategies And Solutions]( "Early Development Fact Sheet")
Leverage an innovative partner with proven expertise in early development to ensure quick problem solving, speed and results.
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The pressure to file an IND makes accelerated Phase I safety testing a priority. With the Quick to Clinic program, Thermo Fisher Scientific can deliver your large molecule drug substance for First-in-Human studies in as little as 12 months. Now you can meet important milestones – such as filing the IND – or secure additional funding with all the confidence your project needs and, we can supply. Because helping you reduce the time it takes to get your discovery to the patients who need it matters, our Quick to Clinic for Biologics is made with speed and flexibility.
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In the contract pharmaceutical industry quality, compliance, and expertise have become cost of entry. Faster separations, mass detection, Quality-by-Design, and new analytical technologies and services can all add value.
