Search results for: Brian W. Pack

Items from 1 to 12 out of 12 results

article

Development of an in vivo-relevant drug product performance method for an amorphous solid dispersion

Brian W. Pack, Yelizaveta Babayan, Mark A. Schrad, Paul A. Stroud, more

Journal of Pharmaceutical and Biomedical Analysis > 2017 > 142 > C > 307-314

The purpose of this work was to develop a meaningful in vitro dissolution method for evacetrapib spray-dried dispersion (SDD) tablets that is discriminating for crystalline drug substance (DS) content. Justification of the method conditions included evaluation of dissolution media, rotation speed, surfactant selection and level of surfactant to achieve sink conditions. Discrimination was illustrated...

article

Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations

Teresa R. Henry, Lara D. Penn, Jason R. Conerty, Francesca E. Wright, more

The AAPS Journal > 2016 > 18 > 6 > 1418-1423

Non-clinical dose formulations (also known as pre-clinical or GLP formulations) play a key role in early drug development. These formulations are used to introduce active pharmaceutical ingredients (APIs) into test organisms for both pharmacokinetic and toxicological studies. Since these studies are ultimately used to support dose and safety ranges in human studies, it is important to understand not...

article

Absolute bioavailability of evacetrapib in healthy subjects determined by simultaneous administration of oral evacetrapib and intravenous [¹³C₈]‐evacetrapib as a tracer

Ellen A. Cannady, Aktham Aburub, Chris Ward, Chris Hinds, more

Journal of Labelled Compounds and Radiopharmaceuticals > 59 > 6 > 238 - 244

This open‐label, single‐period study in healthy subjects estimated evacetrapib absolute bioavailability following simultaneous administration of a 130‐mg evacetrapib oral dose and 4‐h intravenous (IV) infusion of 175 µg [¹³C₈]‐evacetrapib as a tracer. Plasma samples collected through 168 h were analyzed for evacetrapib and [¹³C₈]‐evacetrapib using high‐performance liquid chromatography/tandem mass...

article

Modernization of Physical Appearance and Solution Color Tests Using Quantitative Tristimulus Colorimetry: Advantages, Harmonization, and Validation Strategies

Brian W. Pack, Laura L. Montgomery, Evan M. Hetrick

Journal of Pharmaceutical Sciences > 104 > 10 > 3299 - 3313

Color measurements, including physical appearance, are important yet often misunderstood and underappreciated aspects of a control strategy for drug substances and drug products. From a patient safety perspective, color can be an important control point for detecting contamination, impurities, and degradation products, with human visual acuity often more sensitive for colored impurities than instrumental...

article

Assessing mass balance in pharmaceutical drug products: New insights into an old topic

Steven W. Baertschi, Brian W. Pack, Cherokee S. Hoaglund Hyzer, Mark A. Nussbaum

Trends in Analytical Chemistry > 2013 > 49 > Complete > 126-136

Mass balance is an important concept in pharmaceutical development, but it often proves challenging to assess accurately. This article explores the various methods by which mass balance can and should be measured, expressed, and evaluated in conjunction with degradation chemistry. Causes of mass-balance issues and potential solutions are summarized, as are the advantages and the disadvantages of various...

article

Integrating tristimulus colorimetry into pharmaceutical development for color selection and physical appearance control: A quality‐by‐design approach

Evan M. Hetrick, Jeffrey Vannoy, Laura L. Montgomery, Brian W. Pack

Journal of Pharmaceutical Sciences > 102 > 8 > 2608 - 2621

The color of pharmaceutical dosage forms can be an important aspect of product branding and patient compliance with a dosing regimen. During the development of drug products, it is important to understand the stability of not only the active pharmaceutical ingredient but also the color and appearance of the tablet or capsule. Currently, the most common method to ensure color stability is to conduct...

article

The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product

Linda K. Dow, Marvin M. Hansen, Brian W. Pack, Todd J. Page, more

Journal of Pharmaceutical Sciences > 102 > 5 > 1404 - 1418

The strategies implemented at Eli Lilly and Company to address European Medicines Agency and US Food and Drug Administration requirements governing the control of genotoxic impurities (GTIs) are presented. These strategies were developed to provide understanding with regard to the risk and potential liabilities that could be associated with developmental and marketed compounds. The strategies systematize...

chapter

Cleaning Verification for Highly Potent Compounds

Brian W. Pack

Formulation and Analytical Development for Low‐Dose Oral Drug Products > Challenges in Analytical Method Development for Oral Low‐Dose Drug Products > 345 - 380

This chapter contains sections titled: Introduction Cleaning Validation vs Cleaning Verification Acceptance Limit Calculations Analytical Method Validation General Analytical Techniques Analytical Techniques for Low‐Dose Compounds Conclusions Acknowledgments References

article

The effect of analyte acidity on signal suppression and the implications to peak purity determinations using atmospheric pressure ionization mass spectrometry

Kristine Liao, Brian W. Pack, Nicholas P. Toltl

Journal of Pharmaceutical and Biomedical Analysis > 2007 > 44 > 1 > 118-126

The effect of a co-eluting halogenated phenol, spiked at 1% of the main analyte level, has been examined for a series of halogenated phenols using LC–MS techniques. Similarly, the effect of co-eluting anilines has been investigated. The purpose of the work presented here was to evaluate the degree of signal suppression for structurally similar halogenated phenols and for similar anilines utilizing...

article

Cleaning verification assays for highly potent compounds by high performance liquid chromatography mass spectrometry: Strategy, validation, and long-term performance

Li Liu, Brian W. Pack

Journal of Pharmaceutical and Biomedical Analysis > 2007 > 43 > 4 > 1206-1212

A cleaning-verification assay was validated for a highly potent family of compounds utilizing a swab-sampling procedure and high performance liquid chromatography mass spectrometry (LC-MS) for separation and detection of the analytes. Due to the high potency of the compound, the LC-MS method was validated at a level of 50ng/25cm ² and 50ng/100cm ² (which equates to 10ng/ml after extraction...

article

Evaluation of a monolithic silica column operated in the hydrophilic interaction chromatography mode with evaporative light scattering detection for the separation and detection of counter-ions

Brian W. Pack, Donald S. Risley

Journal of Chromatography A > 2005 > 1073 > 1-2 > 269-275

In this work a monolithic silica column operated in the hydrophilic interaction chromatography (HILIC) mode in conjunction with an evaporative light scattering detector (ELSD) was investigated. Lithium, sodium and potassium were used as the test counter-ions for this evaluation. Chromatographic properties of this column operated in the HILIC mode were determined by varying key mobile phase parameters,...

article

An improved microwave plasma torch for atomic spectrometry

Brian W. Pack, Gary M. Hieftje

Spectrochimica Acta Part B: Atomic Spectroscopy > 1997 > 52 > 14 > 2163-2168

The analytical performance of a microwave plasma torch was improved through mechanical alterations. Several problems reported in earlier designs were addressed: the ignition and stabilization of a helium plasma in the MPT was difficult; high powers were required to both ignite and operate the plasma; otherwise, the plasma would erratically change from an annular to a filament type discharge. In the...

Filter options

Publication date

Set your own date range

INFONA - science communication portal

Search results for: Brian W. Pack

Add recipient

Sending message cancelled

Are you sure you want to cancel sending this message?

Send message

Filter options

Publication date

Date range setting

Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.

Publication type

Keywords

Data set

Journal

Reporting an error / abuse

Sending the report failed

Accessibility options