CDEK: Clinical Drug Experience Knowledgebase

Abstract The Clinical Drug Experience Knowledgebase (CDEK) is a database and web platform of active pharmaceutical ingredients with evidence of clinical testing as well as the organizations involved in their research and development. CDEK was curated by disambiguating intervention and organization names from ClinicalTrials.gov and cross-referencing these entries with other prominent drug databases. Approximately 43% of active pharmaceutical ingredients in the CDEK database were sourced from ClinicalTrials.gov and cannot be found in any other prominent compound-oriented database. The contents of CDEK are structured around three pillars: active pharmaceutical ingredients (n = 22 292), clinical trials (n = 127 223) and organizations (n = 24 728). The envisioned use of the CDEK is to support the investigation of many aspects of drug development, including discovery, repurposing opportunities, chemo- and bio-informatics, clinical and translational research and regulatory sciences.

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CDEK: Clinical Drug Experience Knowledgebase

10.1101/474189 ◽

2018 ◽

Author(s):

Rebekah Griesenauer ◽

Constantino Schillebeeckx ◽

Michael S Kinch

Keyword(s):

Clinical Trials ◽

Active Pharmaceutical Ingredients ◽

Clinical Testing ◽

Drug Experience ◽

Pharmaceutical Ingredients ◽

Drug Databases ◽

Regulatory Sciences ◽

Web Platform ◽

Clinical Drug ◽

Clinical And Translational Research

The Clinical Drug Experience Knowledgebase (CDEK) is a database and web platform of active pharmaceutical ingredients with evidence of clinical testing as well as the organizations involved in their research and development. CDEK was curated by disambiguating intervention and organization names from ClinicalTrials.gov and cross-referencing these entries with other prominent drug databases. Approximately 43% of active pharmaceutical ingredients in the CDEK database were sourced from ClinicalTrials.gov and cannot be found in any other prominent compound-oriented database. The contents of CDEK are structured around three pillars: active pharmaceutical ingredients (n = 22,292), clinical trials (n = 127,223), and organizations (n = 24,728). The envisioned use of the CDEK is to support the investigation of many aspects of drug development, including discovery, repurposing opportunities, chemo- and bio-informatics, clinical and translational research, and regulatory sciences.

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Funding of clinical trials in Brazil for the development of new drugs: who are the sponsors?

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20151236 ◽

2015 ◽

Vol 2 (4) ◽

pp. 75 ◽

Cited By ~ 1

Author(s):

Ricardo Eccard da Silva ◽

Angélica Amorim Amato ◽

Maria Rita Carvalho Garbi Novaes

Keyword(s):

Clinical Trials ◽

Pharmaceutical Industry ◽

The Other ◽

New Drugs ◽

Essential Medicines ◽

Neglected Diseases ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Funding Sources ◽

Other Hand

Background: A low rate of investment in science it is directly impacts the technological independence and capacity in health care costs. Knowledge of funding sources is critical to understand the problem and formulates hypotheses for future studies.Methods: Two databases were used: the System for Control of Clinical Research (SCCR) from the Brazilian Health Surveillance Agency (Anvisa), and the International Clinical Trials Registry Platform (ICTRP). Results: From 2009 to 2012, 77% of the clinical trials approved by Anvisa were sponsored by transnational pharmaceutical industry. On the other hand, the national pharmaceutical industry sponsored 8% of the trials over the same period. The most frequent sponsor of clinical trials involving drugs registered in the ICTRP from 2011 to 2012 was the transnational pharmaceutical industry (43%). Among the trials with national sponsors, are those involving neglected diseases such as chronic hepatitis C (ICD X B18.2), cutaneous leishmaniasis (ICD X B55.1) and yellow fever (ICD X A95), which were all sponsored by national governmental foundations. None of the active pharmaceutical ingredients studied by the transnational pharmaceutical industry or the transnational biopharmaceutical company were in the national list of essential medicines. On the other hand, 83% and 66.6% of the active pharmaceutical ingredients studied by national private universities and the international governmental agency, respectively, are in the national list of essential medicines. Conclusions: The national pharmaceutical industry and government still invests little in Research and Development (R&D) activities, when compared with transnational industries. This affects directly its technological and innovation ability.

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CLINICAL TRIALS IN IRKUTSK SCIENTIFIC CENTER OF SURGERY AND TRAUMATOLOGY: RESULTS AND PROSPECTS

Бюллетень Восточно-Сибирского научного центра Сибирского отделения Российской академии медицинских наук ◽

10.12737/23000 ◽

2016 ◽

Vol 1 (4) ◽

pp. 129-134

Author(s):

Демкова ◽

Olga Demkova ◽

Апарцин ◽

Konstantin Apartsin ◽

Горохова ◽

...

Keyword(s):

Clinical Trials ◽

Trial Protocol ◽

Scientific Journals ◽

Clinical Testing ◽

Drug Trials ◽

Scientific Center ◽

Observational Trial ◽

Multicentre Trials ◽

Clinical Drug Trials ◽

Clinical Drug

Clinical drug trials in Irkutsk Scientific Center of Surgery and Traumatology began in 2005. In 2013, the laboratory of clinical trials was established in the science department of clinical surgery. We analyzed the experience of Irkutsk Scientific Center of Surgery and Traumatology in international multicentre trials. Participation in international mul-ticentre trials allows the Irkutsk Scientific Center of Surgery and Traumatology to get affiliated with the publications in first quartile scientific journals. The experience of the laboratory in clinical trials is projected into practical work of other institutes – Hospital of Irkutsk Scientific Center SB RAS and Irkutsk Regional Clinical Hospital. The important objectives of the laboratory of clinical trials are developing the protocols, performing drug clinical trials and medical device clinical trials. The laboratory carries out admission of patients for observational trial PROTOCOL. One of the fields of work of the laboratory is the prospect of clinical testing of developed clinical technologies.

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Guide for auditing manufacturing of active pharmaceutical ingredients for clinical trials

The Quality Assurance Journal ◽

10.1002/1099-1786(199812)3:4<153::aid-qaj77>3.0.co;2-c ◽

1998 ◽

Vol 3 (4) ◽

pp. 153-207

Author(s):

Good Manufacturing Practice Committee of the French Society of Quality Assurance

Keyword(s):

Clinical Trials ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients

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Reversed-Phase High Performance Liquid Chromatographic Analysis of Three First Line Anti-Tuberculosis Drugs

Revista de Chimie ◽

10.37358/rc.18.12.6799 ◽

2019 ◽

Vol 69 (12) ◽

pp. 3590-3592

Author(s):

Nela Bibire ◽

Romeo Iulian Olariu ◽

Luminita Agoroaei ◽

Madalina Vieriu ◽

Alina Diana Panainte ◽

...

Keyword(s):

High Performance ◽

Biological Fluids ◽

Gradient Elution ◽

High Performance Liquid Chromatographic ◽

Reversed Phase ◽

Assay Method ◽

Active Pharmaceutical Ingredients ◽

First Line ◽

Pharmaceutical Ingredients ◽

Liquid Chromatographic

Active pharmaceutical ingredients such as isoniazid, pyrazinamide and rifampicin are among the most important first-line anti-tuberculosis drugs. A simple, rapid and sensitive reversed phase-high performance liquid chromatographic assay method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin has been developed. Separation of the interest compounds was achieved in a 10 min chromatographic run in gradient elution mode on a Zorbax SB-C18 stainless steel column (150 � 4 mm, 5 mm) using a guard column containing the same stationary phase. The gradient elution was carried out with a mobile phase of 10% CH3CN aqueous solution for channel A and 50% CH3CN in pH = 6.8 phosphate buffer (20 mM), to which 1.5 mL triethylamine were added for channel B. Quantification of the analyzed substances was carried out spectrophotometrically at 269 nm. Detection limits of 0.48 mg/L for isoniazid, 0.52 mg/L for pyrazinamide and 0.48 mg/L for rifampicin were established for the developed assay method. The present work showed that the proposed analysis method was advantageous for simple and rapid analysis of the active pharmaceutical ingredients in pharmaceuticals and biological fluids.

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Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins

AMB Express ◽

10.1186/s13568-021-01204-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Bach-Ngan Nguyen ◽

Florian Tieves ◽

Thomas Rohr ◽

Hilke Wobst ◽

Felix S. Schöpf ◽

...

Keyword(s):

Fermentation Broth ◽

High Titer ◽

New Technology ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Expression Platform ◽

Small Proteins ◽

Production Platform ◽

Β Amyloid ◽

Cost Efficient

AbstractThe production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.

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Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

Molecules ◽

10.3390/molecules26030610 ◽

2021 ◽

Vol 26 (3) ◽

pp. 610

Author(s):

Mariann Inga Van Meter ◽

Salah M. Khan ◽

Brynne V. Taulbee-Cotton ◽

Nathan H. Dimmitt ◽

Nathan D. Hubbard ◽

...

Keyword(s):

Mass Spectrometry ◽

Mass Spectrometry Imaging ◽

Laser Desorption ◽

Ionization Mass Spectrometry ◽

Ionization Mass ◽

Active Pharmaceutical Ingredients ◽

Laser Desorption Ionization ◽

Over The Counter ◽

Pharmaceutical Ingredients ◽

Desorption Ionization

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

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Sulfanyl Porphyrazines with Morpholinylethyl Periphery—Synthesis, Electrochemistry, and Photocatalytic Studies after Deposition on Titanium(IV) Oxide P25 Nanoparticles

Molecules ◽

10.3390/molecules26082280 ◽

2021 ◽

Vol 26 (8) ◽

pp. 2280

Author(s):

Tomasz Koczorowski ◽

Wojciech Szczolko ◽

Anna Teubert ◽

Tomasz Goslinski

Keyword(s):

Diclofenac Sodium ◽

2D Nmr ◽

Oxide Nanoparticles ◽

Electrochemical Studies ◽

Macrocyclic Compounds ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Vis Spectroscopy ◽

Singlet Oxygen Quencher ◽

Nmr Techniques

The syntheses, spectral UV–Vis, NMR, and electrochemical as well as photocatalytic properties of novel magnesium(II) and zinc(II) symmetrical sulfanyl porphyrazines with 2-(morpholin-4-yl)ethylsulfanyl peripheral substituents are presented. Both porphyrazine derivatives were synthesized in cyclotetramerization reactions and subsequently embedded on the surface of commercially available P25 titanium(IV) oxide nanoparticles. The obtained macrocyclic compounds were broadly characterized by ESI MS spectrometry, 1D and 2D NMR techniques, UV–Vis spectroscopy, and subjected to electrochemical studies. Both hybrid materials, consisting of porphyrazine derivatives embedded on the titanium(IV) oxide nanoparticles’ surface, were characterized in terms of particle size and distribution. Next, they were subjected to photocatalytic studies with 1,3-diphenylisobenzofuran, a known singlet oxygen quencher. The applicability of the obtained hybrid material consisting of titanium(IV) oxide P25 nanoparticles and magnesium(II) porphyrazine derivative was assessed in photocatalytic studies with selected active pharmaceutical ingredients, such as diclofenac sodium salt and ibuprofen.

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US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/1741134321994316 ◽

2021 ◽

pp. 174113432199431

Author(s):

María Fabiana Jorge

Keyword(s):

Supply Chain ◽

Trade Policy ◽

Pharmaceutical Products ◽

Drug Supply ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Us Trade Policy ◽

Drug Supply Chain ◽

Security Concern ◽

The U.S

With the outbreak of the Coronavirus there is a new realization of the vulnerabilities of the U.S. drug supply chain. However, while such concerns may have been amplified by the pandemic, they preceded Covid-19 and were well documented before 2020. Indeed, in past years the U.S. Congress held several hearings addressing potential vulnerabilities in the U.S. drug supply chain, in part due to the increasing dependency on China as a dominant supplier of active pharmaceutical ingredients (APIs) and some finished pharmaceutical products. These vulnerabilities go well beyond health policy and constitute a national security concern. The article addresses how U.S. trade policy plays a significant role in shaping the pharmaceutical industry at home and abroad and is in part responsible for some of the current vulnerabilities of the U.S. drug supply chain.

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