Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 4
Abstract
The online version of this article (doi:10.1208/s12248-015-9762-4) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Yan G. Ni, Xiling Yuan, John A. Newitt, Jon E. Peterson, Carol R. Gleason, Jonathan Haulenbeek, Rasa Santockyte, Virginie Lafont, Frank Marsilio, Robert J. Neely, Binodh DeSilva, Steven P. Piccoli
Keywords
Related Articles
- EP ID EP680980
- DOI 10.1208/s12248-015-9762-4
- Views 71
- Downloads 0
Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges
Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with...
Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects
Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of gener...
The Pharmacokinetics and Interactions of Ivermectin in Humans—A Mini-review
Ivermectin is an antiparasitic drug with a broad spectrum of activity, high efficacy as well as a wide margin of safety. Since 1987, this compound has a widespread use in veterinary medicine and it use has been extended...
Progressively Reducing Regulatory Burden
Principles of dissolution science have been applied to allow waiver of in vivo bioequivalence studies for oral immediate release solid dosage forms, providing certain stipulations are met. This approach reduces regulator...
Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data
The aim of this study was to demonstrate the value of mechanistic simulations in gaining insight into the behaviors of modified release (MR) formulations in vivo and to use the properly calibrated models for prediction o...