Published in The AAPS Journal
Development and validation of a bioanalytical method for biosimilar biological product development (BPD) can be challenging. It requires the development of a bioanalytical method that reliably and accurately measures both proposed biosimilar and reference products in a biological matrix. This survey summarizes the current state of bioanalysis in BP...
Published in The AAPS Journal
Thorough exploration of alternative dosing frequencies is often not performed in conventional pharmacometrics approaches. Quantitative systems pharmacology (QSP) can provide novel insights into optimal dosing regimen and drug behaviors which could add a new dimension to the design of novel treatments. However, methods for such an approach are curre...
Published in The AAPS Journal
Pharmacokinetic studies are key to evidence-based pharmacotherapy. The reliability of pharmacokinetic parameters is closely related to the quality of bioanalytical data. Bioanalytical method validation is fully described by regulatory guidelines; however, it is conducted just once. To ensure reliability and comparability of clinical data, appropria...
Published in The AAPS Journal
The emergence and continued evolution of the transporter field has caused re-evaluation and refinement of the original principles surrounding drug disposition. In this paper, we emphasize the impact that transporters can have on volume of distribution and how this can affect the other major pharmacokinetic parameters. When metabolic drug–drug inter...
Published in The AAPS Journal
Clinical trial endpoints often take the form of bounded outcome scores (BOS) which report a discrete set of values on a finite range. Conceptually such endpoints are ordered categorical in nature, but in practice they are often analyzed as continuous variables, which may result in data range violations and difficulties to handle data skewness. Anal...
Published in The AAPS Journal
The development of analytical techniques to study therapeutic monoclonal antibodies is expected to be useful for pharmacokinetic analysis and for the development of therapeutic indexes to determine dosage standards. To date, the blood concentration of antibody drugs has been analyzed by the enzyme-linked immunosorbent assay (ELISA). However, with t...
Published in The AAPS Journal
The authors regret that Fig. 7d for the group: LPS+M-2 (80 μM) was mistakenly uploaded.
Published in The AAPS Journal
The extrapolation of oral bioavailability (F) information between dogs and humans has had an important role in the drug development process, whether it be to support an assessment of potential human pharmaceutical formulations or to identify the bioavailability challenges that may be encountered in dogs. Accordingly, these interspecies extrapolatio...
Published in The AAPS Journal
Gemini surfactants are promising molecules utilized as non-viral gene delivery vectors. However, little is known about their cellular uptake and distribution after they release their therapeutic cargo. Therefore, we quantitatively evaluated the cellular uptake and distribution of three gemini surfactants: unsubstituted (16-3-16), with pyridinium he...
Published in The AAPS Journal
Assumptions inherent to pharmacometric model development and use are not routinely acknowledged, described, or evaluated. The aim of this work is to present a framework for systematic evaluation of assumptions. To aid identification of assumptions, we categorise assumptions into two types: implicit and explicit assumptions. Implicit assumptions are...
