Advertisement

Topics

PubMed Journals Articles About "Drug Testing Products" RSS

01:19 EST 19th December 2018 | BioPortfolio

Drug Testing Products PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Drug Testing Products articles that have been published worldwide.

More Information about "Drug Testing Products" on BioPortfolio

We have published hundreds of Drug Testing Products news stories on BioPortfolio along with dozens of Drug Testing Products Clinical Trials and PubMed Articles about Drug Testing Products for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Drug Testing Products Companies in our database. You can also find out about relevant Drug Testing Products Drugs and Medications on this site too.

Showing "Drug Testing products" PubMed Articles 1–25 of 16,000+

Can synthetic urine replace authentic urine to "beat" workplace drug testing?

Synthetic urine (SU), which was primarily utilized by drug testing laboratories as matrix for quality control preparations, are now commercially sold and can be used to "fool" a positive drug test. To determine if SU can pass as authentic urine, we challenged Army urine drug testing collection and testing procedures using eight different commercial SU products. Adulteration (Sciteck AdultaCheck® 6) and Onsite SU (Synthetic UrineCheck ) test strips were also evaluated. Five of the eight SU were identified b...


3D printed drug delivery and testing systems - a passing fad or the future?

The US Food and Drug Administration approval of the first 3D printed tablet in 2015 has ignited growing interest in 3D printing, or additive manufacturing (AM), for drug delivery and testing systems. Beyond just a novel method for rapid prototyping, AM provides key advantages over traditional manufacturing of drug delivery and testing systems. These includes the ability to fabricate complex geometries to achieve variable drug release kinetics; ease of personalising pharmacotherapy for patient and lowering t...

Assessment of the results of a 3-Year Program for National Standardization and Quality Improvement of Medical Laboratories on Drug of Abuse Testing by the Ministry of Health in Turkey.

The aim of this study is to assess the results of inspections in the last 3 years on drug abuse testing in medical laboratories according to the last regulations in Turkey.


Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release from Nifedipine Extended-Release Tablets.

In contrast to nifedipine matrix-based extended-release dosage forms, the osmotic pump drug delivery systems have a zero-order drug release independent of external variables such as pH, agitation rate, and dissolution media. The objective of this study focuses on the in vitro evaluation of the mechanical properties of osmotic pump and polymer matrix-based formulations in dissolution media and the potential impacts that media pH and simulated gastrointestinal contraction have on drug release. Two strengths o...

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway.

In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially o...

Identification of degradation products of praziquantel during the mechanochemical activation.

Praziquantel (PZQ) is an inexpensive, low toxicity BCS II class anthelmintic drug used for the treatment of neglected tropical diseases. In earlier papers a mechanochemical activation has been used to induce physical transformations on the drug which would ameliorate its solubility and hence its bioavailability and a systematic study of the effects of varying temperature, frequency and time of milling on drug melting enthalpy and drug recovery was given. In this communication, the focus is on the degradatio...

New Approach for the Application of USP Apparatus 3 in Dissolution Tests: Case Studies of Three Antihypertensive Immediate-Release Tablets.

The USP Apparatus 3 is a compendial dissolution Apparatus that has been mainly used to assess the performance of modified-release drug products. However, this Apparatus can be applied to dissolution testing of immediate-release tablets as well, with several advantages such as lower consumption of dissolution media, reduced setup time in quality control routine, and minimized hydrodynamic issues. In this work, three immediate-release (IR) tablets containing antihypertensive drugs of different Biopharmaceutic...

Current practices for viability testing of cryopreserved cord blood products: an international survey by the cellular therapy team of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative.

Viability testing is a common practice in laboratories. The goal of this study was to ascertain current laboratory practices internationally for performing viability testing for cryopreserved cord blood (CB) products and glean information about how to standardize the method to improve interlaboratory reproducibility.

Enrichment of Relevant Oxidative Degradation Products in Pharmaceuticals with Targeted Chemoselective Oxidation.

The ability to produce and isolate relatively pure amounts of relevant degradation products is key to several aspects of drug product development: (a) aid in the unambiguous structural identification of such degradation products, fulfilling regulatory requirements to develop safe formulations (ICH Q3B and M7); (b) pursue as appropriate safety evaluations with such material, such as chronic toxicology or Ames testing; (c) for a specified degradation product in a late-stage regulatory filing, utilize pure and...

Drug Quality In South Africa: A Field Test.

To assess drug quality and pharmaceutical care in South Africa, "mystery" (i.e. anonymous) customers collected 316 samples from July to September 2016. Solid dosage forms containing amoxicillin alone or in combination with clavulanic acid as well as analgesics containing paracetamol alone or in combination were sampled in a randomized fashion from the formal market (pharmacies) and by convenient sampling from the informal market. Visual inspection, uniformity of dosage units and dissolution testing were per...

Drug resistance mechanisms and drug susceptibility testing for tuberculosis.

Tuberculosis (TB) caused by Mycobacterium tuberculosis (MTB) is the deadliest infectious disease and the associated global threat has worsened with the emergence of drug resistance, in particular multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). Although the World Health Organization (WHO) End-TB Strategy advocates for universal access to antimicrobial susceptibility testing, this is not widely available and/or it is still underused. The majority of drug resistance in clinical MTB ...

Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inadvertent Inhalation Exposure to Consumers.

The potential for inadvertent inhalation of over-the-counter (OTC) aerosol/powder drug products for topical application requires understanding of the characteristic size distributions of the airborne particles or droplets generated when these products are used as per the directions on the product label. Particle/droplet size is an important factor in determining the depth of particle penetration into the respiratory system following inhalation. Because particles penetrating beyond the larynx into the lung m...

Characterization of solution stress degradation products of aliskiren and prediction of their physicochemical and ADMET properties.

Forced degradation studies on aliskiren were carried out according to ICH and WHO guidelines. Six degradation products were formed in total in the solution state. Their separation among themselves and from the drug was successfully achieved on a C-18 column utilizing acetonitrile and phosphate buffer (pH 3.0) in the mobile phase, which was run in a gradient mode. To characterize them, a complete mass fragmentation pathway of the drug was first established with the help of MS/TOF and MS data. This was foll...

A large single hospital experience using drug provocation testing and rapid drug desensitization in hypersensitivity to antineoplastic and biological agents.

Large-scale studies of Drug Provocation Testing (DPT) or Rapid Drug Desensitization (RDD) for hypersensitivity to antineoplastics and biologicals are scarce and limited to a few institutions OBJECTIVE: Our aim was to review our experience with DPT and RDD in a large number of patients with a history of hypersensitivity to antineoplastics and biologicals and summarize the practical implications of that experience.

Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products.

In recent decades, extensive emphasis has been given on developing nanopharmaceutical products for improving the therapeutic performance of drugs, resulting in an increasing number of product approvals by drug regulatory agencies. Although nanopharmaceuticals are subjected to the same regulatory pathways as conventional pharmaceutical products, their biopharmaceutical characteristics at the nanoscale make them vulnerable to high variability in quality. Positive effects on drug quality assurance have resulte...

A study of cryogenic tissue-engineered liver slices in calcium alginate gel for drug testing.

To address issues such as transportation and the time-consuming nature of tissue-engineered liver for use as an effective drug metabolism and toxicity testing model, "ready-to-use" cryogenic tissue-engineered liver needs to be studied. The research developed a cryogenic tissue-engineered liver slice (TELS), which comprised of HepG2 cells and calcium alginate gel. Cell viability and liver-specific functions were examined after different cryopreservation and recovery culture times. Then, cryogenic TELSs were ...

A case study demonstrating the migration of diethyl phthalate from an ancillary component to the drug product.

Phthalates are chemical compounds employed as plasticizers in the plastic industry and have been reported to migrate into drug products. The extent of their migration into the drug product depends upon various factors including the chemical nature of the migrant and the permeability of its packaging container. Migration of semi-volatile phthalates such as Diethyl phthalate (DEP) into drug products is often related to the primary and secondary packaging but due to its chemical nature, it could also migrate f...

Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug.

Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives.

An Innovative, Collaborative, and Strategic Approach to Proactively Evaluate and Update Drug Interactions Based on Prescribing Information of Newly Approved Medicinal Products.

Drug-drug interaction (DDIs) are evaluated using pharmacokinetic (PK) simulation models, clinical studies, and scientific publications throughout drug development. DDIs with Norvir (ritonavir) and combination products (eg, Kaletra [lopinavir/ritonavir]) containing ritonavir as a PK enhancer are relevant, because these drugs could affect exposures of CYP3A4 substrates. Application of algorithms proactively identified recently approved drugs, which potentially cause adverse outcomes when given with drugs cont...

In further defense of nonclinical abuse liability testing of biologics.

Risk assessment is not a choice. Drug Abuse Liability (DAL) is mandated under international and national drug control statutes for all drugs targeting the CNS. Once administered to humans many biologics may have long-lived or permanent physiological effects that make DAL testing arduous. We respond to premises of a recently published position on DAL testing of biologics by de Zafra et al. (2018). We propose that, at a minimum, Sponsors submitting a Biologics Licensure Application (BLA) must think "outside t...

The Price of Precision: Genetic Testing and Drug Costs in America.

Novel degradation products of argatroban: Isolation, synthesis and extensive characterization using NMR and LC-PDA-MS/Q-TOF.

Forced degradation study of argatroban under conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH Q1A (R2), was accomplished. The drug showed significant degradation under hydrolysis (acidic, alkaline) and oxidation (peroxide stress) conditions. The drug remained stable under thermal and photolytic stress conditions. In total, seven novel degradation products (DP1 to DP7) were found under diverse conditions, which were not reported earlie...

A cheminformatic insight into the differences between terrestrial and marine originated natural products.

This is a new golden age for the drug discovery based on natural products derived from both marine and terrestrial sources. Herein, a straightforward but important question is what are the major structural differences between marine natural products (MNPs) and terrestrial natural products (TNPs). To answer this question, we analyzed the important physicochemical properties, structural features and drug-likeness of the two types of natural products and discussed their differences from the perceptive of evolu...

Skin Sensitization Induction Potential From Daily Exposure to Fragrances in Personal Care Products.

Many chemicals used for fragrance purposes in a diversity of products have allergenic potential. Based on such concerns, industry groups developed concentration limits for use of fragrance chemicals in personal care and cosmetic products.

To Test or Not To Test?: The Value of Toxicology in a Delayed Overdose Death.

A case demonstrating the necessity of thorough death investigation processes where toxicology plays an active role is presented. A 33-year-old white man presented to the emergency room in respiratory distress after an overdose episode where he was revived on the scene by fire rescue. His condition continued to deteriorate and he expired 6 days after the initial incident. No admission specimens were available for testing; however, there were specimens drawn 4 and 5 days after the incident. Drug paraphernalia...


Advertisement
Quick Search
Advertisement
Advertisement