Search

Monitoring the characteristic components in tipping paper is important to ensure the quality of cigarette products. This study establishes a method based on gas chromatography (GC) for determining cooling agents in tipping paper. The tipping paper was cut into pieces and extracted by ethanol under specific temperatures in a shaker. Then, the characteristic cooling agents of (-)-menthone, L-menthol, and (-)-menthyl lactate in extract were determined using GC coupled with a flame ionization detector (GC-FID). The limits of detection (LODs) and limits of quantification (LOQs) for the three cooling agents ranged from 0.15~0.32 μg/mL and 0.49~1.06 μg/mL, respectively. Results demonstrated a good linear relationship with high correlation coefficients for the three tested cooling agents. The extraction conditions of the cooling agents were optimized through a single-factor experiment as well as an orthogonal experiment. The standard addition recovery experiment showed that the average recoveries range from 81.23 to 100.62%, and the relative standard deviations (RSDs) of the measured values (n = 5) ranged from 0.34 to 1.64%. [ABSTRACT FROM AUTHOR]

The article presents a present a methodical qualitative and quantitative analysis of H-Classic publications that have made key contributions and identify intensive mainstream research areas in atomic spectroscopy. It mentions that the study also provides an insight into historical developments in atomic spectroscopy, which can be valuable to academic organizations and editorial staff in determining areas and fields of research.

The article offers information on the importance of data in drug development and the life sciences industry. Topics include the use of new technologies like AI and machine learning for data collection and analysis, the persistence of paper-based processes in the industry, and challenges such as the "first-mile problem" in data collection and management.

The article reports that the gestation period for the Pharmaceutical Inspection Co-operation Scheme (PIC/S) PI-041 data integrity guidance, and a draft 3 was issued for public comment in November 2018, with the final version issued in July 2021. It mentions that Good Practices for Data Management and Integrity in Regulated od distribution practice (GDP) or good manufacturing practice (GMP) environment with a document number PI-041.

The article reports that physicians who do not use electronic health records (EHRs) say using paper charts avoids many of the hassles and frustrations that physicians often experience practicing medicine. It mentions that EHRs require physicians to spend a portion of each patient visit entering often-irrelevant data such as when the patient last had an eye exam or dental checkup.

The article discusses the challenges of detecting host cell proteins (HCPs) in biologics manufacturing, and provides recommendations on what can be done in-house and when outsourcing is a better option. It mentions that the most common method for HCP detection is enzyme-linked immunosorbent assay (ELISA), but coverage assessment of HCP antibodies can be challenging, making outsourcing to experienced labs a viable option.

The article presents the discussion on showing the concern in the atomic spectroscopy community. Topics include authors being computer scientists not realizing the gaps due to the lack of familiarity with field of atomic spectroscopy; and specialized applications in areas like material science, physics, clinical applications, and astrobiology.

The article explores how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing. Topics discussed include achieving bioavailability of highly lipophilic drugs that are practically water insoluble; and suitable surfactant at an appropriate concentration in the aqueous dissolution medium is a key element for quantitative rupture testing of these soft gel formulations.

The article provides an overview of the technology involved in scanning, reviewing and signing documents, along with tips for pediatricians on expediting their document workflow. Topics covered the division of documents into various piles, the complexity added by electronic health records to the process of document handling and the problems encountered with scanned documents.

The article presents some ways the organization providing with various continuing education (CE) platforms and informational resources for veterinary professionals. It discusses arranging the distance-learning sessions including live webinars, on-demand webinars, talk show video programs, and "The Vet Blast" podcasts.

In the article, the author discusses the effectiveness of digitization by life-sciences companies to improve their compliance with good manufacturing practices (GMP) required by the U.S. Food and Drug Administration (FDA). Also cited are the paper-based processes as main threat to GMP compliance, how a pharmaceutical packaging firm used a cloud-based batch record system to boost worker efficiency and reduce GMP-related quality reviews, and the digital quality management system (QMS) benefits.

The article focuses on the transformative impact of digital technologies on the life sciences industry, emphasizing the adoption of electronic quality management systems (eQMS) to navigate evolving regulatory landscapes and enhance efficiency. Topics include the constant changes in global industry compliance, the challenges of managing paper-based systems in a digital era, and the pivotal role of eQMS in fostering organizational growth and compliance with regulatory requirements.

In this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution. The method introduced here can be broadly applied to multiple polymeric excipient types. Ion-exchange chromatography post-column derivatization is used to determine ultra-low levels of nitrite in three excipients. [ABSTRACT FROM AUTHOR]

The reasons the DEA set forth in denying a one-time transfer of unfilled hard copy prescriptions is their portability and the patient's ability to be handed back the prescription by the pharmacist. January 20, 2022 Agency aims to allow electronic prescriptions for schedule II to V drugs between registered retail pharmacies on 1-time basis for initial fill. The US Drug Enforcement Administration (DEA) has issued a notice of proposed rulemaking to address the transfer of electronically prescribed controlled substances. [Extracted from the article]

The article presents an end user perspective on the utility of the electronic health record during the COVID-19 pandemic, as of November 2021. Topics covered include how the public health crisis has motivated rapid innovation of EHRs, the first EHR changes that end users saw and how updates to patient communication proved essential in managing the surge of patient messages and calls. It also discusses the shift to telemedicine and the limitations of the impact of the EHR progress.

Spectroscopy is publishing a series of feature articles highlighting the lives and careers of the most influential spectroscopists over the past 100 years. These individuals were selected by our Editorial Advisory Board and team of editors to represent the leading figures in spectroscopy over the century. Our second featured Icon of Spectroscopy is Peter R. Griffiths. [ABSTRACT FROM AUTHOR]

The article focuses on EMA's promotion of real-world data (RWD) in non-interventional studies for generating real-world evidence (RWE), addressing methodological aspects, governance, and data quality, aligning closely with FDA guidance but highlighting differences in NIS definitions, aiming to enhance regulatory decision-making and scientific rigor while improving transparency and reliability of industry-generated RWD.

The article focuses on the potential for point-of-care (POC) manufacturing in the biopharmaceutical industry. Topics include the emergence of advanced manufacturing technologies and regulatory considerations, the benefits of distributed manufacturing and technological advancements for ensuring drug quality, and the relevance of POC manufacturing for cell and gene therapies.

The article informs that Trupanion wants to inspire veterinary professionals to save paper, and make a donation to the Arbor Day Foundation if veterinary professionals take time to hear more about the paperless program.

The article highlights a growing challenge for bioprocess contract manufacturing services in 2023, with over a third of contract manufacturing organizations struggling to retain skilled technical and production staff, causing capacity constraints. Topics include Staff shortages are problematic in areas like process development, upstream, and downstream processing, utilization of automation, and the increasing demand for experienced staff.

This opinion paper seeks to introduce a disruptive model to accelerate product and process development in the biopharmaceutical industry, especially for vaccines. This model is based on the minimum valuable product and process (MVaP&P), a new concept that allows for adaptation and acceleration, which would enable agility in the way biopharmaceuticals are developed. This article discusses how the MVaP&P approach would make it is possible to discipline and structure biopharmaceutical development to achieve a phase-appropriate and strategy-aligned product in the fastest time possible. [ABSTRACT FROM AUTHOR]

The article mentions the American College of Physicians' (ACP) release of a policy paper on the ethical and professional implications of healthcare business practices and physician employment as of April 2021.

The article reports that a white paper published by the American Urological Association (AUA) and the Society of Urologic Nurses and Associates states that risk assessment should be performed in all men undergoing prostate biopsy to determine their risk of complications and alternative strategies should be used to prevent these complications. Topics covered include bleeding complications being the most prevalent after prostate biopsy.

Good Manufacturing Practice (GMP) is the most significant regulation impacting the pharmaceutical industry and requires substantial investment in resources and time commitments. This paper provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards. It discusses GMP compliance requirements and practices, emphasizing those relevant to the analytical chemist in development and quality control. [ABSTRACT FROM AUTHOR]

Computerized System Validation (CSV) is usually associated with great mountains of paper (GMP). Why should this be the case? Ask yourself, am I lazy? Why write multiple documents if only one is required to validate a spectrometer with a simple intended use? Interested? Read on. [ABSTRACT FROM AUTHOR]

Stability studies are carried out to study the impact on the quality of drug substance or drug product over a period of time under the combined influence of environmental factors like temperature, humidity, and exposure to light. One of the main purpose of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability. The spreadsheet is designed to meet the poolability criteria as per International Council for Harmonisation Harmonised Tripartite guideline for evaluation of stability data, Q1E. [ABSTRACT FROM AUTHOR]

Q. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become ubiquitous for the quantitative determination of small molecules in food and feed samples. For LC-MS using both high-resolution (HR) MS and tandem MS, matrix components coeluting with analytes of interest influence the ionization efficiency of the latter. Q. A further paper published in 2020 presents a comprehensive quantitative LC-MS/MS approach for the analysis of agrocontaminants in animal feeds. [Extracted from the article]

Stability data of samples of pharmaceuticals are often generated as replicate test results, typically as duplicates. A statistical analysis for determination of an expiration date can then be applied on either the replicates or their corresponding averages in line with the methodology suggested in ICH Q1A(R2) and Q1E guides. This paper aims at clarifying when a shelf-life derived from all replicates or averages is justified and correct. When replicate stability data represent preparations of the same sample, this is a case of pseudoreplication, and, therefore, the statistically derived shelf-life should be based on the averages of the replicates. However, when these replicate data represent independently and randomly selected and tested samples at each time point, a statistically derived shelf-life based on all replicate data is justifiable. [ABSTRACT FROM AUTHOR]

The article provides information on benzene in benzoyl peroxide (BPO) products, reported by testing laboratory Valisure and reviewed by Dr. Christopher Bunick at the 2024 American Academy of Dermatology Annual Meeting. Valisure tested 66 BPO products and found high levels of benzene when BPO products were incubated. Bunick offered a history of benzene through academic papers and provided practical recommendations for BPO products.

The article discusses how pharmaceutical articles submitted to the periodical Pharmaceutical Technology (PharmTech) are peer-reviewed before being published. According to the author, in today's time when fake news and pay-for-publish models are being adopted by other publications, PharmTech has in place an editorial advisory board to review the submitted articles. The board members and the authors are anonymous to each other, thus confirming the credibility of the technical or scientific work.