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Efficacy and safety of abrocitinib in Chinese patients with moderate-to-severe atopic dermatitis: A post hoc analysis of the JADE REGIMEN phase 3 trial

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中华医学杂志(英文版) 2024年第16期137卷 1991-1992页

作者： Li Hang Cheng Hao Lu Qianjin Lai Wei Tao Xiaohua Encinas Gerardo A. Vyas Shefali Wang Bo Luo Xin Li Shiqi Department of Dermatology Peking University First Hospital National Clinical Research Center for Skin and Immune Diseases Beijing China Department of Dermatology Sir Run Run Shaw Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China Department of Dermatology The Second Xiangya Hospital of Central South University Changsha Hunan China Department of Dermatology The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China Department of Dermatology Zhejiang Provincial People’s Hospital Hangzhou Medical College Hangzhou Zhejiang China pfizer S.A. de C.V. Mexico City Mexico pfizer Inc. New York NY USA pfizer Investment Co. Ltd Beijing China pfizer (China) R& D Co. Ltd Shanghai China pfizer PBG Shanghai China

Epidemiology of EGFR Mutation in Adenocarcinoma NSCLC Patients in India: A Systematic Review and Meta-Analysis

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Advances in Lung Cancer 2024年第1期13卷 1-21页

作者： Ankita Jain Kumar Prabhash Venkatraman Radhakrishnan Shashank Srinivasan pfizer Products India Private Limited Mumbai India Tata Memorial Hospital Mumbai India Cancer Institute (W.I.A.) Chennai India

Studies reporting the Indian prevalence of Epidermal Growth Factor Receptor (EGFR) mutation are mostly single centers with small sample sizes. This systematic review and meta-analysis summarized the available evidence of EGFR mutation epidemiology in Indian patients with adenocarcinoma (ADC) Non-Small Cell Lung Cancer (NSCLC). We conducted a structured literature search in PubMed, and EMBASE databases from January 2004 through October 2019. The primary outcome of interest was prevalence of EGFR mutation by gender, smoking status, and mutation subtype. The review included 34 studies. EGFR mutation prevalence was 39.5% in patients with ADC, and significantly higher in females, non-smokers, and patients with exon 19 deletions. The EGFR mutation frequency in Indian patients with ADC was higher than reported in Caucasians but at a lower range of that reported in East Asians. These findings support the use of EGFR mutation testing to guide choice of treatment.

关键词： Epidemiology Epidermal Growth Factor Receptor Adenocarcinoma Non-Small Cell Lung Cancer India

Critical questions in development of targeted nanoparticle therapeutics

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Regenerative Biomaterials 2016年第2期3卷 143-147页

作者： Richard Korsmeyer Pharmaceutical Sciences Pfizer Worldwide R&DGrotonCT 06340USA

One of the fourteen Grand Challenges for Engineering articulated by the US National Academy of Engineering is‘Engineer Better Medicines’.Although there are many ways that better medicines could be engineered,one of the most promising ideas is to improve our ability to deliver the therapeutic molecule more precisely to the desired *** conventional drug delivery methods(oral absorption,intravenous infusion etc.)result in systemic exposure to the therapeutic molecule,which places severe constraints on the types of molecules that can be used.A molecule administered by systemic delivery must be effective at low concentrations in the target tissue,yet safe everywhere else in the *** drug carriers could be developed to deliver therapeutic molecules selectively to the desired target,it should be possible to greatly improve safety and efficacy of ***(and related nanostructures,such as liposomes,nanoemulsions,micelles and dendrimers)are an attractive drug carrier concept because they can be made from a variety of materials engineered to have properties that allow loading and precise delivery of bound therapeutic *** field of targeted nanoparticles has been extraordinarily active in the academic realm,with thousands of articles published over the last few *** of these publications seem to demonstrate very promising results in in vitro studies and even in animal *** addition,a handful of human clinical trials are in ***,the biopharmaceutical industry has been relatively slow to make major investments in targeted nanoparticle development programs,despite a clear desire to introduce innovative new therapies to the *** is the reason for such caution?Some degree of caution is no doubt due to the use of novel materials and the unproven nature of targeted nanoparticle technology,but many other unproven technologies have generated intense interest at various *** believe that the major barrier to the exploration

关键词： nanoparticles targeting biodistribution manufacturing

Multi-omic study to unmask genes involved in prostate cancer development in amulti-case family

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Cancer Communications 2024年第3期44卷 443-447页

作者： Lucia Chica-Redecillas Sergio Cuenca-Lopez Eduardo Andres-Leon Laura Carmen Terron-Camero Blanca Cano-Gutierrez Jose Manuel Cozar Jose Antonio Lorente Fernando Vazquez-Alonso Luis Javier Martinez-Gonzalez Maria Jesus Alvarez-Cubero GENYO Centre for Genomics and Oncological ResearchPfizerUniversity of GranadaAndalusian Regional GovernmentPTS GranadaGranadaGranadaSpain Department of Biochemistry Molecular Biology III and ImmunologyFaculty of MedicineUniversity of GranadaPTS GranadaGranadaGranadaSpain Bioinformatics Unit Institute of Parasitology and Biomedicine“López-Neyra”Spanish National Research CouncilGranadaGranadaSpain Nursery Service.University Hospital Clínico San Cecilio GranadaGranadaSpain Urology Department University Hospital Virgen de las NievesGranadaGranadaSpain Legal Medicine and Toxicology Department Faculty of MedicineUniversity of GranadaPTS GranadaGranadaGranadaSpain Ibs Biosanitary Research InstituteGranadaGranadaSpain

Dear Editor,Hereditary prostate cancer(PC)comprises 5%-10%of all PC *** increased risk of PC in menwith a family his-tory of the disease is well known and is commonly caused by germline mutations,leading to clinical guidelines men-tioning various genes for identifying high-risk ***,the complex inheritance patterns involvingmul-tiple single nucleotide polymorphisms(SNPs)make it a genetically heterogeneous disease,with genetic testing still in its early stages.

关键词： cancer clinical cases

Nondestructive Quantitative Analysis of Cofrel Medicines by Double ANN-NIR Spectroscopy

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Chinese Chemical Letters 2006年第9期17卷 1209-1212页

作者： Ming Yang LIU Yu MENG Jun Feng LI Hai Tao ZHANG Hong Yan WANG College of Chemistry Jilin University Changchun 130012 pfizer Pharmaceuticals Limited Co. Dalian 116600

In this paper, a double artificial neural network （DANN） algorithm was used to parse near infrared （NIR） reflectance spectrum of Cofrel medicines. The contents of benproperine phosphate, which is the effective ingredient in Cofrel medicines, were accurately nondestructive quantitatively predicted. Compared the results with those of HPLC, the relative errors （RE %） were less than 0.18%. The analytical results could be applied to qualitative control of Cofrel medicines.

关键词： Double ANN NIR spectroscopy nondestructive quantitative analysis Cofrel.

Hepatotoxicity reports in the FDA adverse event reporting system database:A comparison of drugs that cause injury via mitochondrial or other mechanisms

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Acta Pharmaceutica Sinica B 2021年第12期11卷 3857-3868页

作者： Payal Rana Michael D.Aleo Xuerong Wen Stephen Kogut Drug Safety Research&Development PfizerGrotonCT 06340USA University of Rhode Island College of PharmacyKingstonRI 02881USA

Drug-induced liver injury(DILI) is a leading reason for preclinical safety attrition and postmarket drug ***-induced mitochondrial toxicity has been shown to play an essential role in various forms of DILI,especially in idiosyncratic liver *** study examined liver injury reports submitted to the Food and Drug Administration(FDA) Adverse Event Reporting System(FAERS) for drugs associated with hepatotoxicity via mitochondrial mechanisms compared with non-mitochondrial mechanisms of *** frequency of hepatotoxicity was determined at a group level and individual drug level.A reporting odds ratio(ROR) was calculated as the measure of *** the two DILI groups,reports for DILI involving mitochondrial mechanisms of toxicity had a 1.43(95% CI 1.42-1.45;P 18:benzbromarone,troglitazone,isoniazid,rifampin) were associated with mitochondrial mechanisms of *** major demographic influence for DILI risk was also *** was a higher mean patient age among reports for drugs that were associated with mitochondrial mechanisms of toxicity [56.1±18.33(SD)] compared to non-mitochondrial mechanisms [48±19.53(SD)](P <0.0001),suggesting that age may play a role in susceptibility to DILI via mitochondrial mechanisms of *** logistic regression analysis showed that reports of liver injury were 2.2(odds ratio:2.2,95% CI 2.12-2.26) times more likely to be associated with older patient age,as compared with reports involving patients less than 65 years of *** to males,female patients were 37% less likely(odds ratio:0.63,95% CI

关键词： Mitochondrial toxicity FAERS database Adverse event reporting Drug-induced liver injury Hepatotoxicity

The Prevalence of Methicillin-Resistant Staphylococcus aureus Colonization in Patients with Complicated Skin and Skin Structure Infections after Treatment with Linezolid or Vancomycin

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Advances in Infectious Diseases 2014年第4期4卷 186-193页

作者： Laura A. Puzniak Kimbal D. Ford David B. Huang formerly pfizer Inc. Collegeville USA pfizer Inc. Collegeville USA

Background: Complicated skin and skin structure infections (cSSSIs) due to Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA), are associated with significant morbidity. Re-ducing MRSA carriage has been a focus of infection control interventions. The prevalence of MRSA colonization after successful treatment of a MRSA cSSSI is unknown. Methods: Secondary analysis of a randomized controlled trial comparing linezolid and vancomycin for the treatment of MRSA cSSSI. Adult patients that had a colonization culture, confirmed MRSA cSSSI, received at least one dose of study treatment, and had an outcome recorded at end of study. Patient, clinical characteristics and prevalence of colonization were compared by treatment regimens. A multivariate regression model identified predictors of MRSA colonization at EOS. Results: There were 456 patients evaluated. The prevalence of MRSA colonization was higher for vancomycin treated patients compared to linezolid treated patients at end of treatment (EOT) (28% vs. 5%, p < 0.001) and EOS (34% vs. 22%, p < 0.01). Independent predictors of colonization at EOS after treatment for a MRSA cSSSI included diagnosis, primarily driven by abscess, black race, treatment with vancomycin, MRSA mixed infection and male gender. Conclusion: Patients treated with linezolid for a cSSSI had less MRSA colonization at EOT and EOS compared to those treated with vancomycin. Multiple independent predictors of MRSA colonization were identified. Additional studies evaluating the relationship of MRSA colonization after treatment of cSSSI are needed.

关键词： Staphylococcus aureus Complicated Skin and Skin Structure Infection Colonization Linezolid

Pharmacological inhibition of diacylglycerol acyltransferase-1 and insights into postprandial gut peptide secretion

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World Journal of Gastrointestinal Pathophysiology 2017年第4期8卷 161-175页

作者： Benjamin S Maciejewski Tara B Manion Claire M Steppan pfizer Worldwide Research and Development Cardiovascular and Metabolic Diseases Research Unit pfizer Inc.

AIM To examine the role that enzyme Acyl-CoA:diacylglycerol acyltransferase-1(DGAT1) plays in postprandial gut peptide secretion and *** The standard experimental paradigm utilized to evaluate the incretin response was a lipid *** a lipid challenge,plasma was collected via cardiac puncture at each time point from a cohort of 5-8 mice per group from baseline at time zero to 10 *** hormones [glucagon like peptide-1(GLP-1),peptide tyrosine-tyrosine(PYY) and glucose dependent insulinotropic polypeptide(GIP)] were then *** impact of pharmacological inhibition of DGAT1 on the incretin effect was evaluated in WT ***,a comparison of loss of DGAT1 function either by genetic ablation or pharmacological *** further elucidate the pathways and mechanisms involved in the incretin response to DGAT1 inhibition,other interventions [inhibitors of dipeptidyl peptidase-IV(sitagliptin),pancreatic lipase(Orlistat),GPR119 knockout mice] were *** DGAT1 deficient mice and wildtype C57/BL6J mice werelipid challenged and levels of both active and total GLP-1 in the plasma were *** response was further augmented with DGAT1 inhibitor PF-04620110 treated wildtype ***,PF-04620110 was able to dose responsively increase GLP-1 and PYY,but blunt GIP at all doses of PF-04620110 during lipid *** treatment of PF-04620110 and Sitagliptin in wildtype mice during a lipid challenge synergistically enhanced postprandial levels of active *** contrast,in a combination study with Orlistat,the ability of PF-04620110 to elicit an enhanced incretin response was *** further explore this observation,GPR119 knockout mice were *** response to a lipid challenge,GPR119 knockout mice exhibited no increase in active or total GLP-1 and ***,PF-04620110 was able to increase total GLP-1 and PYY in GPR119 knockout mice as compared to vehicle treated wildtype ***

关键词： Glucagon-like peptide-1 Peptide tyrosinetyrosine Glucose independent insulinotropic peptide Acyl-CoA diacylglycerol acyltransferase-1 Incretin

Innovative Approaches in Safety Assessment of New Therapeutics:Global Perspectives

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Innovative Approaches in Safety Assessment of New Therapeuti...