scholarly journals Method validation in pharmaceutical analysis: from theory to practical optimization

2015 ◽  
Vol 6 (1) ◽  
Author(s):  
Jaqueline Kaleian Eserian ◽  
Márcia Lombardo

The validation of analytical methods is required to obtain high-quality data. For the pharmaceutical industry, method validation is crucial to ensure the product quality as regards both therapeutic efficacy and patient safety. The most critical step in validating a method is to establish a protocol containing well-defined procedures and criteria. A well planned and organized protocol, such as the one proposed in this paper, results in a rapid and concise method validation procedure for quantitative high performance liquid chromatography (HPLC) analysis.   Type: Commentary

Soziale Welt ◽  
2020 ◽  
Vol 71 (1-2) ◽  
pp. 3-23 ◽  
Author(s):  
Irena Kogan ◽  
Frank Kalter

Given the recent surge in interest in refugee research, this editorial discusses whether the study of refugees’ migration and integration requires entirely new theoretical and methodological approaches. We make the case that refugee migration is a special type of migration and that refugee integration is subject to similar laws and regularities as the integration of all kinds of immigrants. Therefore, it should be studied using conventional theoretical and analytical approaches to empirical-analytical migration and integration research. Obviously, special conditions of refugee migration apply, such as specific patterns of refugees’ selectivity, health and resource endowment, settlement conditions, and reception or integration services. However, such peculiarities do not represent distinct mechanisms; they are simply background conditions for more general mechanisms. Contributions to this Special Issue, which all rely on new high-quality data from Germany, best highlight the universality of general mechanisms of immigrant integration, on the one hand, and the relevance of refugee migrants’ specific characteristics and conditions, on the other hand.


2020 ◽  
Author(s):  
James McDonagh ◽  
William Swope ◽  
Richard L. Anderson ◽  
Michael Johnston ◽  
David J. Bray

Digitization offers significant opportunities for the formulated product industry to transform the way it works and develop new methods of business. R&D is one area of operation that is challenging to take advantage of these technologies due to its high level of domain specialisation and creativity but the benefits could be significant. Recent developments of base level technologies such as artificial intelligence (AI)/machine learning (ML), robotics and high performance computing (HPC), to name a few, present disruptive and transformative technologies which could offer new insights, discovery methods and enhanced chemical control when combined in a digital ecosystem of connectivity, distributive services and decentralisation. At the fundamental level, research in these technologies has shown that new physical and chemical insights can be gained, which in turn can augment experimental R&D approaches through physics-based chemical simulation, data driven models and hybrid approaches. In all of these cases, high quality data is required to build and validate models in addition to the skills and expertise to exploit such methods. In this article we give an overview of some of the digital technology demonstrators we have developed for formulated product R&D. We discuss the challenges in building and deploying these demonstrators.<br>


Author(s):  
Mary Kay Gugerty ◽  
Dean Karlan

Without high-quality data, even the best-designed monitoring and evaluation systems will collapse. Chapter 7 introduces some the basics of collecting high-quality data and discusses how to address challenges that frequently arise. High-quality data must be clearly defined and have an indicator that validly and reliably measures the intended concept. The chapter then explains how to avoid common biases and measurement errors like anchoring, social desirability bias, the experimenter demand effect, unclear wording, long recall periods, and translation context. It then guides organizations on how to find indicators, test data collection instruments, manage surveys, and train staff appropriately for data collection and entry.


1986 ◽  
Vol 49 (5) ◽  
pp. 383-388 ◽  
Author(s):  
PETER SPORNS ◽  
SUET KWAN ◽  
LAWRENCE A. ROTH

Oxytetracycline (OTC), also known commercially as Terramycin, was determined to be more stable in honey than in buffered aqueous solutions at similar pH values and temperatures. A rapid high performance liquid chromatography (HPLC) method was developed to detect and quantitate OTC using a 1:1 dilution (wt/wt) of honey samples in water. Using 355 nm as the wavelength of detection, amounts as low as 0.5 μg/ml could be detected in the above solution. The limits of detection were lowered considerably by a double extraction procedure.


2019 ◽  
Vol 14 (3) ◽  
pp. 338-366
Author(s):  
Kashif Imran ◽  
Evelyn S. Devadason ◽  
Cheong Kee Cheok

This article analyzes the overall and type of developmental impacts of remittances for migrant-sending households (HHs) in districts of Punjab, Pakistan. For this purpose, an HH-based human development index is constructed based on the dimensions of education, health and housing, with a view to enrich insights into interactions between remittances and HH development. Using high-quality data from a HH micro-survey for Punjab, the study finds that most migrant-sending HHs are better off than the HHs without this stream of income. More importantly, migrant HHs have significantly higher development in terms of housing in most districts of Punjab relative to non-migrant HHs. Thus, the government would need policy interventions focusing on housing to address inequalities in human development at the district-HH level, and subsequently balance its current focus on the provision of education and health.


2017 ◽  
Vol 47 (1) ◽  
pp. 46-55 ◽  
Author(s):  
S Aqif Mukhtar ◽  
Debbie A Smith ◽  
Maureen A Phillips ◽  
Maire C Kelly ◽  
Renate R Zilkens ◽  
...  

Background: The Sexual Assault Resource Center (SARC) in Perth, Western Australia provides free 24-hour medical, forensic, and counseling services to persons aged over 13 years following sexual assault. Objective: The aim of this research was to design a data management system that maintains accurate quality information on all sexual assault cases referred to SARC, facilitating audit and peer-reviewed research. Methods: The work to develop SARC Medical Services Clinical Information System (SARC-MSCIS) took place during 2007–2009 as a collaboration between SARC and Curtin University, Perth, Western Australia. Patient demographics, assault details, including injury documentation, and counseling sessions were identified as core data sections. A user authentication system was set up for data security. Data quality checks were incorporated to ensure high-quality data. Results: An SARC-MSCIS was developed containing three core data sections having 427 data elements to capture patient’s data. Development of the SARC-MSCIS has resulted in comprehensive capacity to support sexual assault research. Four additional projects are underway to explore both the public health and criminal justice considerations in responding to sexual violence. The data showed that 1,933 sexual assault episodes had occurred among 1881 patients between January 1, 2009 and December 31, 2015. Sexual assault patients knew the assailant as a friend, carer, acquaintance, relative, partner, or ex-partner in 70% of cases, with 16% assailants being a stranger to the patient. Conclusion: This project has resulted in the development of a high-quality data management system to maintain information for medical and forensic services offered by SARC. This system has also proven to be a reliable resource enabling research in the area of sexual violence.


2019 ◽  
Vol 101 (4) ◽  
pp. 658-666 ◽  
Author(s):  
Romain Gauriot ◽  
Lionel Page

We provide evidence of a violation of the informativeness principle whereby lucky successes are overly rewarded. We isolate a quasi-experimental situation where the success of an agent is as good as random. To do so, we use high-quality data on football (soccer) matches and select shots on goal that landed on the goal posts. Using nonscoring shots, taken from a similar location on the pitch, as counterfactuals to scoring shots, we estimate the causal effect of a lucky success (goal) on the evaluation of the player's performance. We find clear evidence that luck is overly influencing managers' decisions and evaluators' ratings. Our results suggest that this phenomenon is likely to be widespread in economic organizations.


2006 ◽  
Vol 21 (1) ◽  
pp. 67-70 ◽  
Author(s):  
Brian H. Toby

The definitions for important Rietveld error indices are defined and discussed. It is shown that while smaller error index values indicate a better fit of a model to the data, wrong models with poor quality data may exhibit smaller values error index values than some superb models with very high quality data.


Author(s):  
Hsiu-Chuan Yen ◽  
Yi-Tzu Hsu

AbstractHigh-performance liquid chromatography (HPLC) with electrochemical detection was used to analyze lipidsoluble antioxidants and micronutrients in plasma. Small amounts of plasma samples are often extracted in polypropylene (PP) microcentrifuge tubes before HPLC analysis due to its convenience. We therefore investigated the effect of impurities released from different PP tubes during extraction on the electrochemical detection of retinol, lutein, α-tocopherol, γ-tocopherol, retinyl palmitate, β-carotene and total coenzyme Q


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