Detection of pyrovalerone as a possible synthetic by-product of 4′-methyl-α-pyrrolidinohexanophenone and 4-methyl-α-ethylaminopentiophenone in illicit drug products
Sign Up to like & getrecommendations! Published in 2018 at "Forensic Toxicology"
DOI: 10.1007/s11419-018-0407-z
Abstract: PurposeImpurity profiling is an important intelligence-gathering tool that can be used to link batches of drugs, and it provides valuable insights into manufacturing and supply trends in new psychoactive substances. In a routine analysis, we… read more here.
Keywords: methyl; illicit drug; pyrovalerone; drug products ... See more keywords
Challenges and Considerations in Development and Manufacturing of High Concentration Biologics Drug Products
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Pharmaceutical Innovation"
DOI: 10.1007/s12247-019-09414-3
Abstract: With the advent of novel biotherapeutics in indications such as oncology, the attention has moved to making these therapies patient centric, potentially available for self-administration. Given the volume limitations of the other convenient routes of… read more here.
Keywords: development manufacturing; concentration; drug products; high concentration ... See more keywords
Small differences in acidic pH condition significantly affect dissolution equivalence between drug products of acidic drug salt
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Drug Delivery Science and Technology"
DOI: 10.1016/j.jddst.2021.102546
Abstract: Abstract The dissolution profile of a drug product in the stomach has been assessed by an in vitro dissolution test using a single acidic pH condition (typically pH 1.2). However, there are inter- and intra-individual… read more here.
Keywords: drug products; drug; dissolution test; dissolution ... See more keywords
Pharmaceutical Cocrystal Drug Products: An Outlook on Product Development.
Sign Up to like & getrecommendations! Published in 2018 at "Trends in pharmacological sciences"
DOI: 10.1016/j.tips.2018.10.006
Abstract: Active pharmaceutical ingredients (APIs) are most commonly formulated and delivered to patients in the solid state. Recently, an alternative API solid-state form, namely the pharmaceutical cocrystal, has witnessed increasing academic and industrial interest due to… read more here.
Keywords: cocrystal drug; drug products; product; drug ... See more keywords
Dissolution Failure of Solid Oral Drug Products in Field Alert Reports.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2017.01.014
Abstract: From 2005 to 2014, 370 data entries of dissolution failures of solid oral drug products were assessed with respect to the solubility of drug substances, dosage forms [immediate release (IR) vs. modified release (MR)], and… read more here.
Keywords: dissolution failure; oral drug; solid oral; drug products ... See more keywords
Challenges of using closed system transfer devices with biological drug products - An industry perspective.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2019.10.042
Abstract: Hazardous drug is a common term used by National Institute of Occupational Health and Safety (NIOSH) to classify medications that may induce adverse mutagenic and reproductive responses in healthcare personnel. NIOSH publishes a list of… read more here.
Keywords: transfer devices; drug products; drug; closed system ... See more keywords
Putative Phospholipase B-like 2 is not responsible for polysorbate degradation in monoclonal antibody drug products.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2020.05.028
Abstract: Polysorbates (PS) are surfactants commonly added in a therapeutic protein drug product as excipients to protect proteins from denaturation and aggregation during storage, transportation, and delivery. Significant degradation of PS in drug products could lead… read more here.
Keywords: polysorbate degradation; degradation; drug products; drug ... See more keywords
Development of Drug Products for the Treatment of Acute Radiation Syndrome
Sign Up to like & getrecommendations! Published in 2024 at "Disaster Medicine and Public Health Preparedness"
DOI: 10.1017/dmp.2023.227
Abstract: Abstract The Food and Drug Administration’s (FDA) approval to market drug products for use as medical countermeasures, to prevent or mitigate injury caused by various threat agents, is commonly based on evidence of efficacy obtained… read more here.
Keywords: acute radiation; radiation; drug products; development ... See more keywords
Ultrasensitive Quantification Method for Understanding Biologically Relevant Concentrations of Host Cell Proteins in Therapeutics.
Sign Up to like & getrecommendations! Published in 2023 at "Analytical chemistry"
DOI: 10.1021/acs.analchem.3c00020
Abstract: Certain host cell proteins (HCPs) in biotherapeutic drugs may be detrimental to drug product quality even when they are present at the subppm level. Therefore, an analytical method that can reliably quantify trace amounts of… read more here.
Keywords: quantification; ppm; cell proteins; drug products ... See more keywords
Pharmacokinetic Bioequivalence between Generic and Originator Orally Inhaled Drug Products: Validity of Administration of Doses above the Approved Single Maximum Dose.
Sign Up to like & getrecommendations! Published in 2024 at "Molecular pharmaceutics"
DOI: 10.1021/acs.molpharmaceut.4c00479
Abstract: Pharmacokinetic bioequivalence of orally inhaled drug products is a critical component of the US FDA's "weight of evidence" approach, and it can serve as the sole indicator of safety and effectiveness of follow-on inhalation products… read more here.
Keywords: bioequivalence; inhaled drug; single maximum; drug products ... See more keywords
Accelerated shelf life modeling of appearance change in drug products using ASAPprime ®
Sign Up to like & getrecommendations! Published in 2022 at "Pharmaceutical Development and Technology"
DOI: 10.1080/10837450.2022.2112223
Abstract: Abstract An accelerated stability model approach was demonstrated to accurately predict the long-term shelf life of example drug substances and drug products (indigo carmine tablets and L-ascorbic acid powder) where appearance changes were shelf life–limiting.… read more here.
Keywords: shelf life; appearance changes; drug products;