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Special Issue "Recent Trends in Pharmaceutical Analytical Chemistry"

A special issue of Molecules (ISSN 1420-3049). This special issue belongs to the section "Analytical Chemistry".

Deadline for manuscript submissions: 31 December 2019

Special Issue Editors

Guest Editor
Dr. Constantinos K. Zacharis

Laboratory of Pharmaceutical Analysis, Department of Pharmaceutical Technology, School of Pharmacy, Aristotle University of Thessaloniki, Greece
Website | E-Mail
Interests: pharmaceutical analytical chemistry; method development and validation; sample preparation (derivatization, microextraction, etc); liquid and gas chromatography; capillary electrophoresis; mass spectrometry
Guest Editor
Assoc. Prof. Aikaterini Markopoulou

Laboratory of Pharmaceutical Analysis, Department of Pharmaceutical Technology, School of Pharmacy, Aristotle University of Thessaloniki, Greece
Website | E-Mail
Interests: liquid and gas chromatography; mass spectrometry; FT-Raman; Near-IR; chemometrics and implementation techniques; study and modeling of the retention mechanism of drugs on HPLC columns; drug-likeness by modeling and HPLC; bioanalysis; modern pharmaceutical formulations

Special Issue Information

Dear Colleagues,

Modern analytical chemistry plays a vital role in pharmaceutical sciences. It provides identification and quantification data supporting drug discovery, purity of drug substances during its synthesis, pharmacokinetic studies, drug stability, elucidation of the drug metabolic pathways, drug-protein interactions, etc. New methodologies, state-of-the art instrumentation and materials, automated systems - offering precise and accurate analytical data – have become an important prerequisite in this field. Furthermore, chemometrics is a useful tool for the optimization of method parameters and also to identify and minimize the sources of variability that may lead to poor method robustness.

The present Special Issue will include review and full-length research articles covering the latest research trends and applications of Pharmaceutical Analytical Chemistry. Analytical scientists working on method development and validation, impurity profiling, pharmacokinetics, drug-protein/DNA interaction studies, bioanalysis, enantioseparation, etc are cordially invited to contribute a research or review article in this Special Issue. The degree of novelty and the significant of the research will be scrutinized prior to peer-reviewing process.

In the cases of review articles an additional brief (1-2 pages) description of the topic including a draft index is required. This preliminary step is essential to avoid overlapping of topics.

Dr. Constantinos K. Zacharis
Dr. Aikaterini Markopoulou
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Molecules is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1800 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • impurity profiling
  • enantioseparation
  • bioanalytical chemistry
  • analytical quality by design (AQbD) - Chemometrics
  • separation techniques (LC, GC, CE, SFC, LC x LC, etc)
  • pharmacokinetics, Bioequivalence studies
  • drug-protein/DNA binding studies
  • automation
  • quality control & stability
  • sample preparation

Published Papers (1 paper)

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Research

Open AccessArticle
A Cell-Based Strategy for Bioactivity Determination of Long-Acting Fc-Fusion Recombinant Human Growth Hormone
Molecules 2019, 24(7), 1389; https://doi.org/10.3390/molecules24071389
Received: 27 February 2019 / Revised: 7 April 2019 / Accepted: 8 April 2019 / Published: 9 April 2019
PDF Full-text (1462 KB) | HTML Full-text | XML Full-text
Abstract
The long-acting growth hormone (LAGH) is a promising alternative biopharmaceutical to treat growth hormone (GH) deficiency in children, and it was developed using a variety of technologies by several pharmaceutical companies. Most LAGH preparations, such as Fc fusion protein, are currently undergoing preclinical [...] Read more.
The long-acting growth hormone (LAGH) is a promising alternative biopharmaceutical to treat growth hormone (GH) deficiency in children, and it was developed using a variety of technologies by several pharmaceutical companies. Most LAGH preparations, such as Fc fusion protein, are currently undergoing preclinical study and clinical trials. Accurate determination of bioactivity is critical for the efficacy of quality control systems of LAGH. The current in vivo rat weight gain assays used to determine the bioactivity of recombinant human GH (rhGH) in pharmacopoeias are time-consuming, expensive, and imprecise, and there are no recommended bioassays for LAGH bioactivity in pharmacopoeias. Therefore, we developed a cell-based bioassay for bioactivity determination of therapeutic long-acting Fc-fusion recombinant human growth hormone (rhGH-Fc) based on the luciferase reporter gene system, which is involved in the full-length human GH receptor (hGHR) and the SG (SIE and GAS) response element. The established bioassay was comprehensively validated according to the International Council for Harmonization (ICH) Q2 (R1) guidelines and the Chinese Pharmacopoeia, and is highly precise, time-saving, simple, and robust. The validated bioassay could be qualified for bioactivity determination during the research, development, and manufacture of rhGH-Fc, and other LAGH formulations. Full article
(This article belongs to the Special Issue Recent Trends in Pharmaceutical Analytical Chemistry)
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