Journal of Pharmaceutical Innovation最新文献

{"title":"Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022","authors":"Isra Dmour","doi":"10.1007/s12247-022-09692-4","DOIUrl":"10.1007/s12247-022-09692-4","url":null,"abstract":"<div><h3>Purpose</h3><p>Assessment of the US FDA-issued WLs content is an educational tool that can be used in the continuous training program of community pharmacists in compounding pharmacies. The study was designed to critically assess FDA warning letters (WLs) issued to compounding pharmacies in 2017–2022 for violations of Current Good Manufacturing Practices (cGMP).</p><h3>Methods</h3><p>Content analysis was used to evaluate WLs issued concerning (1) type of violations; (2) frequency of violations mentioned in the WLs; (3) specific evaluations of the deviations related to compounded sterile products, and (4) evaluation of corrective measures requested by the US FDA.</p><h3>Results</h3><p>A total of 141 WLs were evaluated. The main observed violations in the analyzed WLs were adulterated drug products (130), misbranded drugs (103), unapproved new drug products (42), failure to report adverse events (22), and failure to report drugs (11). Other violations were evaluated related to sterile product compounding with emphasis on personnel qualifications, quality control procedures, equipment, etc.</p><h3>Conclusion</h3><p>The continuous issuance of WLs by the FDA indicates the need for compounding pharmacies become more vigilant to reduce the recurrence of the addressed violations through establishing adequate training/retraining programs. The analysis of issued WLs can serve as a learning tool to help improve compounding procedures, reduce the recurrence of these violations, and enhance patient safeguards.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 3","pages":"965 - 979"},"PeriodicalIF":2.6,"publicationDate":"2022-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40698293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nanosized Intranasal Delivery of Novel Self-Assembled Cubic Liquid Crystals: Formulation and Evaluation","authors":"Gurudatta N. Desai,&nbsp;Panchaxari M. Dandagi,&nbsp;Taufik M. Kazi","doi":"10.1007/s12247-022-09695-1","DOIUrl":"10.1007/s12247-022-09695-1","url":null,"abstract":"<div><h3>Purpose</h3><p>The focus of this research was to develop Almotriptan malate (ALM)-loaded cubosomal in situ gel to improve its permeation through the blood–brain barrier (BBB) with an efficient and quick action when administered through the intranasal route.</p><h3>Method</h3><p>Cubosomes were developed by emulsifying and homogenizing various proportions and concentrations of pluronics F127 (PF127) and glyceryl monooleate (GMO) along with polyvinyl alcohol (PVA) as suggested by the Box–Behnken design (BBD). The desirability function was used to select the optimum cubosomal formula. The developed cubosomes morphology was validated by high resolution transmission electron microscopy (HR-TEM) analysis. Differential scanning calorimetry (DSC) peaks served as proof that the drug was enclosed within the nanocarrier system. A range of concentrations of PF127 (15–21% w/v) were used to formulate and optimize the in situ gel. Ex vivo permeation experiments followed by histopathology studies were also conducted.</p><h3>Results</h3><p>It was observed that particle size (PS) of 177.15 ± 7.85 nm, polydispersity index (PDI) of 0.36 ± 2.55, zeta potential (ZP) of − 21.26 ± 0.19 mV, and entrapment efficiency percentage (EE%) of 72.58 ± 8.82% was obtained with a percent deviation of less than 5. G4 batch consisting of 18% w/v of PF127 demonstrated satisfactory results. Furthermore, the results were in accordance with the phase transition and the formulation displayed a pseudoplastic rheological behavior confirmed by the rheogram. The optimized formulation’s in vitro drug permeation measurements demonstrated 90.69% release after 5 h. The ex vivo permeation also revealed a 2.52 enhancement ratio when compared to plain in situ gel. Histopathology analyses showed a non-toxic effect of the optimized composition on the cellular structure of sheep’s nasal mucosa. A short-term stability analysis revealed that the formulation was stable at room temperature for 3 months.</p><h3>Conclusion</h3><p>ALM-loaded intranasal cubosomal in situ gel is likely to promote patient compliance by delivering immediate relief from migraine pain due to its rapid onset of action and safe dosage form.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 3","pages":"934 - 951"},"PeriodicalIF":2.6,"publicationDate":"2022-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41721556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Box–Behnken Design-Based Optimized Kinetic Approach to Develop an Eco-friendly Analytical Method for the Quantitation of Glimepiride Using Spectrophotometry","authors":"Habibur Rahman","doi":"10.1007/s12247-022-09691-5","DOIUrl":"10.1007/s12247-022-09691-5","url":null,"abstract":"<div><h3>Purpose</h3><p>The prevalence of type 2 diabetes mellitus is one of the global concerns and almost 80% of diabetic patients are treated with oral antidiabetic drugs. GLMP as a prescribed oral antidiabetic drug for diabetic patients enhanced its necessity. Therefore, it is essential to quantify it in several drug formulations and biological samples. Hence, a simple, eco-friendly, validated kinetic spectrophotometric method was developed for quantifying GLMP in commercial dosage forms.</p><h3>Methods</h3><p>The method was based on the oxidation of the GLMP with potassium permanganate. The reaction was followed spectrophotometrically, measuring an increase in absorbance with time at 605 nm. RSM optimized the influence of preliminary experimental variables for the proposed procedure via BBD, a frequently used DoE. Under the optimized conditions, initial rate, fixed-time (at 6.0 min), and equilibrium method (25.0 min) were adopted for constructing the calibration graphs to determine the amount of GLMP. The robustness of the proposed method was performed, and the effect of selected analytical parameters was investigated with alternative conditions employing Youden and Steiner’s test.</p><h3>Results</h3><p>The outcomes of the model were significant. Hence, the performance of the analytical method was validated statistically and through recovery studies using ICH guidelines. Calibration curves were linear in the concentration ranges of 4.0–36.0 µg/ml with a detection limit of 1.60, 1.02, and 1.13 µg/ml for the initial rate, fixed-time, and equilibrium method, respectively. The proposed method’s greenness profile was assessed using the analytical Eco-Scale and found greener in terms of using harmful reagents, energy consumption, and waste production. Statistical comparison of the results is shown in good agreement with the results found by the reference method, indicating no significant difference in accuracy and precision.</p><h3>Conclusion</h3><p>The proposed validated kinetic method is simple, accurate, low cost, safe, and eco-friendly and might be used in research laboratories, hospitals, and pharmaceutical industries for the routine quality control analysis of GLMP in commercial dosage forms.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 3","pages":"893 - 910"},"PeriodicalIF":2.6,"publicationDate":"2022-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41251059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: September 2022, What’s Next?","authors":"Stephen Scypinski","doi":"10.1007/s12247-022-09682-6","DOIUrl":"10.1007/s12247-022-09682-6","url":null,"abstract":"","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 3","pages":"611 - 611"},"PeriodicalIF":2.6,"publicationDate":"2022-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4629776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Electrospun Poly (Vinyl Alcohol) Nanofibrous Mat Loaded with Green Propolis Extract, Chitosan and Nystatin as an Innovative Wound Dressing Material","authors":"Maria S. Morais,&nbsp;Daniela P. F. Bonfim,&nbsp;Mônica L. Aguiar,&nbsp;Wanderley P. Oliveira","doi":"10.1007/s12247-022-09681-7","DOIUrl":"10.1007/s12247-022-09681-7","url":null,"abstract":"<div><h3>Purposes</h3><p>The objective of this work was to produce and characterise biodegradable poly (vinyl alcohol) (PVA) nanofibre loaded with green propolis extract (GPE), chitosan (CS) and nystatin (NYS) alone and in mixtures as a potential wound dressing material.</p><h3>Methods</h3><p>The GPE, NYS and CS1% were loaded in electrospinning compositions based on PVA 7%, 8% and 12% solubilised in milli-Q water or a mixture of water and glacial acetic acid. The electrospinning compositions without actives (blank) and those loaded with actives were characterised by determining the pH, electrical conductivity and rheological properties. An image analysis procedure applied to photomicrographs obtained by scanning electronic microscopy (SEM) allowed the determination of the nanofibres’ diameter distribution and average surface porosity. The disintegration time and swelling ratio of the nanofibre mats were also determined.</p><h3>Results</h3><p>The physicochemical parameters of the electrospinning compositions (pH, electrical conductivity and rheology) and the incorporated active ingredients (GPE, CS and NYS) affected the electrospun nanofibre mats properties. The electrospun nanofibres’ mean diameters and surface porosity ranged from 151.5 to 684.5 nm and from 0.29 ± 0.04 to 0.50 ± 0.05. The PVA/CS electrospun nanofibres fibres exhibited the smallest diameters, high surface porosity, water absorption capacity and disintegration time. The characteristics of the PVA/CS nanofibres mat associated with the biodegradability of the polymers make them a novel material with the potential to be applied as wound and burn dressings.\u0000</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 2","pages":"704 - 718"},"PeriodicalIF":2.6,"publicationDate":"2022-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40350641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Box Behnken Design-Enabled Development of Nanostructured Lipid Carrier Transdermal Patch for Enhancement of Bioavailability of Olmesartan Medoxomil","authors":"Laxmidhar Sahoo,&nbsp;Goutam Kumar Jena,&nbsp;Chandra Sekhar Patro,&nbsp;Ch.Niranjan Patro,&nbsp;Sukanta Satapathy","doi":"10.1007/s12247-022-09675-5","DOIUrl":"10.1007/s12247-022-09675-5","url":null,"abstract":"<div><h3>Objective</h3><p>Olmesartan medoxomil is an antihypertensive agent used for the management of hypertension but it undergoes first-pass metabolism when taken orally and bioavailability is less than 28%. This can be overcome by choosing it for topical administration by loaded with nanostructured lipid carrier (NLC) and prolonging its action.</p><h3>Methods</h3><p>Nanostructured lipid carrier loaded with olmesartan was prepared by high-speed hot homogenization and melt emulsification low-temperature solidification method. The formulation was composed of solid lipid, liquid lipid, surfactants, and polymers. Formulation fabrication and optimization by Box Behnken design with Design Expert software version 8.0.0. The prepared NLC formulations were studied for drug loading, entrapment efficiency, transmission electron microscopy, zeta potential, and particle size and stability study. The transdermal patch loaded with NLC containing olmesartan was fabricated and optimized.</p><h3>Results</h3><p>The optimized NLC formulation of olmesartan was used to fabricate it into transdermal patches. The optimized formulation (NLC F13) was found to possess particle size, zeta potential, polydispersity index, and entrapment efficiency of 284 nm, − 24.16 mV, 0.8, and 80.17%, respectively. The prepared optimized NLC-loaded transdermal patch was evaluated for weight variation, folding endurance, drug content, and drug release; the results were found as 0.074 ± 0.003, 122 ± 2.56, 92.44 ± 1.89, and 94.24 ± 0.832, respectively. In vivo pharmacokinetic study was approved by IAEC Regd. No. 926/PO/Re/S/06/CPCSEA. The study was a comparison of the pure drug (oral), drug-loaded NLC (oral), and drug-loaded NLC patch (transdermal). It was found that AUC _0–24 and AUC _0-∞ of drug-loaded NLC patch were 17.257 ng. h/mL and 34.259 ng. h/mL as compared with pure drug for oral 8.603 ng. h/mL and 16.547 ng.h/mL, respectively. The AUC _0–24 and AUC _0-∞ of drug-loaded NLC for the oral route were found at 17.857 ng. h/mL and 29.727 ng. h/mL, respectively.</p><h3>Conclusion</h3><p>It was found that formulation was optimized successfully and the bioavailability of the drug enhances significantly as compared to the pure drug and drug-loaded NLC for the oral route. So, optimized formulation was a promising drug delivery system for the effective treatment of hypertension.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 4","pages":"1405 - 1419"},"PeriodicalIF":2.6,"publicationDate":"2022-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4847936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020","authors":"Anurag S. Rathore,&nbsp;Yuexia Li,&nbsp;Hemlata Chhabra,&nbsp;Akshat Lohiya","doi":"10.1007/s12247-022-09678-2","DOIUrl":"10.1007/s12247-022-09678-2","url":null,"abstract":"<div><h3>Purpose</h3><p>To launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract development and manufacturing organization, testing laboratories, and packaging labelling facilities) prior to approval. After the products are approved by the FDA, surveillance inspections are performed by the FDA which are risk based as which company and which site will be inspected. The present study examines the causes of warning letters issued by the Center for Drug Evaluation and Research (CDER), FDA to the pharmaceutical companies after post-approval inspections.</p><h3>Methods</h3><p>Warning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study.</p><h3>Results</h3><p>Poor compliance to CGMP and misbranding were the most common reasons for the warning letters. Detailed analysis of CGMP warning letters elucidated three major types of violations, namely deficiencies in process validation, documentation practices (data integrity), and quality control corresponding to 26%, 21%, and 15% warning letters, respectively.</p><h3>Conclusion</h3><p>Review of the analysed letters demonstrates that the FDA’s major concern is over CGMP compliance. To avoid these warning letters, pharmaceutical manufacturers need to improve their quality compliance and focus on creating effective quality management systems that govern the entire manufacturing process, quality control, employee training, and documentation practice. Companies should develop an internal compliance check list and also be ready for corrective measures as and when required.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 2","pages":"665 - 674"},"PeriodicalIF":2.6,"publicationDate":"2022-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40714675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commercial Low Molecular Weight Heparins — Patent Ecosystem and Technology Paradigm for Quality Characterization","authors":"Zarina Iqbal,&nbsp;Saima Sadaf","doi":"10.1007/s12247-022-09665-7","DOIUrl":"10.1007/s12247-022-09665-7","url":null,"abstract":"<div><h2>Abstract\u0000</h2><div><p>Heparin is a subject of ever-growing interest for laboratory researchers and pharmaceutical industry. One of the driving factors is its critical life-saving drug status, which during the COVID-19 pandemic has assumed a central role in disease treatment and/or prevention. Apart, heparin is one amongst few drugs enjoying a “demand constant” status. In 2020, heparin market size was valued to US$6.5 bn., and given the ongoing stability in the COVID-19 health crisis, it is expected to reach US$11.43 bn. by 2027 with yearly growth rate momentum (CAGR) of 3.9% during the forecast period (Pepi et al., Mol Cell Proteomics 20:100,025, 2021). As patent is a limited monopoly, every year, many patents on low molecular weight heparin (LMWH; a chemically or enzymatically degraded product of unfractionated heparin) are losing market exclusivity worldwide, inviting the generic/biosimilar drug manufacturers to capture market share with cheaper drug products. By tracking patent expiration, drugs in patent litigation, regulatory setbacks for innovator companies (such as those seeking data exclusivity or patent term extension), or other unexpected events affecting market demand and competition, generics can make investment decisions in manufacturing off-patent LMWH drug products of commercial significance. However, given the US Food and Drug Administration (FDA), European Medicine Agency (EMA), Drug Regulatory Authority of Pakistan (DRAP), and other regulatory authorities scientifically rigorous standards for generic/biosimilar LMWH drug products marketing approval, the market is secured and momentous for drug makers that could demonstrate through scientific and clinical dataset that the generic/biosimilar LMWH drug product is of the same quality and purity as the innovator drug product. This study presents an overview of the patent landscape of commercially available LMWHs and advanced analytical techniques for their structural and biochemical characterization for quality control and quality assurance during manufacturing and post-marketing. The study also covers FDA, EMA, Health Canada, and DRAP’s current approaches to evaluating the generic/biosimilar LMWH drug products for quality, safety including immunogenicity, and efficacy.</p></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"18 2","pages":"803 - 835"},"PeriodicalIF":2.6,"publicationDate":"2022-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40576441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Optimization of HP-β-CD Inclusion Complex-Based Fast Orally Disintegrating Tablet of Pitavastatin Calcium","authors":"Prachi Pimple,&nbsp;Prabha Singh,&nbsp;Arati Prabhu,&nbsp;Sonika Gupta","doi":"10.1007/s12247-022-09661-x","DOIUrl":"10.1007/s12247-022-09661-x","url":null,"abstract":"<div><h3>Purpose</h3><p>The objective of the present study was to develop HP-β-cyclodextrin inclusion complex-based rapid orally disintegrating tablets of pitavastatin calcium by unique sublimation technique for enhancing solubility and dissolution profile of anti-lipidemic class II drug.</p><h3>Methods</h3><p>The inclusion complex was prepared by a physical mixing method containing HP-β-cyclodextrin and pitavastatin calcium. The inclusion complex formation between the guest and host was confirmed by molecular docking studies. The developed inclusion complex was further characterized using differential scanning calorimetry (DSC), Fourier transform-infrared spectroscopy (FT-IR), powder X-ray diffraction study (PXRD), and scanning electron microscopy studies. Fast orally disintegrating tablets of pitavastatin calcium inclusion complex were developed by a unique sublimation technique employing full factorial design (2⁴) using the Design Expert® software. Independent factors, namely, type of super disintegrants and sublimating agents at varying concentrations, were studied for effect on disintegration time, hardness of the tablet, and in vitro drug release.</p><h3>Results</h3><p>Molecular docking studies showed a score of −8.08. Optimized formulation containing 5% Ac-di-sol, 10% camphor showed hardness of about 3.37 ± 0.11 kg/cm², least disintegration time 15.31 ± 0.32 s, and highest in vitro drug release of 99.11 ± 0.23% at the end of 15 min.</p><h3>Conclusion</h3><p>The employed complexation method enhanced solubility and increased in vitro dissolution of pitavastatin calcium. It was concluded that fast orally disintegrating tablets containing inclusion complex gave desired characteristics which provided rapid onset of action by fast disintegration and could improve patient compliance.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 3","pages":"993 - 1010"},"PeriodicalIF":2.6,"publicationDate":"2022-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-022-09661-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4393511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply","authors":"Philip J. Almeter,&nbsp;James T. Isaacs,&nbsp;Aaron N. Hunter,&nbsp;Bradley S. Henderson,&nbsp;Thomas Platt,&nbsp;Billie J. Mitchell,&nbsp;David Do,&nbsp;Alyssa B. Brainard,&nbsp;Joshua E. Brown,&nbsp;Rachael M. Stone,&nbsp;Bao-Han Nguyen,&nbsp;Matthew F. Warren,&nbsp;Smaran A. Bhaktawara,&nbsp;Megan N. Bossle,&nbsp;Lindsey M. Long,&nbsp;Stephanie P. Zapata,&nbsp;Cinnamon R. Larkin,&nbsp;Thomas A. Lyman,&nbsp;Seth A. Larkin,&nbsp;Jonathan A. Labuhn,&nbsp;Jeffrey W. Reynolds,&nbsp;Erin E. Schuler,&nbsp;Ryan W. Naseman,&nbsp;Gary L. Johnson,&nbsp;Robert A. Lodder","doi":"10.1007/s12247-022-09659-5","DOIUrl":"10.1007/s12247-022-09659-5","url":null,"abstract":"<div><p>Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.\u0000</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"17 2","pages":"269 - 282"},"PeriodicalIF":2.6,"publicationDate":"2022-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-022-09659-5.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"4128158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}