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Can formulation and drug delivery reduce attrition during drug discovery and development--review of feasibility,benefits and challenges

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Acta Pharmaceutica Sinica B 2014年第1期4卷 3-17页

作者： Basavaraj S Guru V.Betageri Western Centre for drug development Western University of Health SciencesPomonaCA 91766USA

drug discovery and development has become longer and costlier *** fear of failure and stringent regulatory review process is driving pharmaceutical companies towards“me too”drugs and improved generics(505(b)(2))*** discontinuance of molecules at late stage clinical trials is common these *** molecules are withdrawn at various stages of discovery and development process for reasons such as poor ADME properties,lack of efficacy and safety *** this review focuses on possible applications of formulation and drug delivery to salvage molecules and improve the *** formulation and drug delivery technologies are suitable for addressing various issues contributing to attrition are discussed in detail.

关键词： drug discovery and development drugability Formulation drug delivery technology

Rationally designed treatment for metastatic colorectal cancer:Current drug development strategies

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World Journal of Gastroenterology 2014年第30期20卷 10288-10295页

作者： Pavlina Spiliopoulou Hendrik-Tobias Arkenau drug development unit Sarah Cannon Research Institute United KingdomLondon W1G 6ADUnited Kingdom UCL Cancer Institute Medical OncologyUniversity College LondonLondon WC1E 6BTUnited Kingdom

The therapeutic landscape of metastatic colorectal cancer(mCRC)has changed substantially with the emergence of new molecularly targeted agents(MTA)usedas single agents or alongside standard *** use of these MTAs extended the overall survival ofpatients with mCRC to a level that current chemotherapeutics alone could not *** addition,improvement in surgical techniques and ablation modalities offer cure to a limited subset of patients with mCRC andMTAs have been found to have a significant role heretoo,as they aid ***,for the majority of patients,mCRC remains an invariably incurabledisease necessitating continued courses of combinedtreatment *** the course of these treatments,either cytotoxic or biological,cancer cells maintain their ability to acquire mitogenic mutations whichrender them resistant to *** challengesremain to identify appropriate subsets of patients whowill most likely benefit from these new MTAs and effectively select these based on validated ***,better knowledge of the biology of colorectal cancer and the mechanisms via which it bypasses blockade of known signalling pathways will help us design better and more rational sequencing of these treatments,so that we can maximise the survivorship of mCRC *** review outlines treatment strategies for known molecular alterations with new MTAs and highlights some promising strategies.

关键词： Colorectal cancer Molecularly targeted therapies drug development

Successful generic drug product development:From research to marketing approval

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Asian Journal of Pharmaceutical Sciences 2016年第1期11卷 35-36页

作者： Suchart Chongprasert Bureau of drug Control Food and Drug Administration

Recently,generic drug products have played an increasingly important role in the health care system globally,especially in the developing world,as they provide for an effective and more affordable alternative for healthcare *** drug products are proven therapeutically equivalent to the corresponding innovator’s product,and hence can be substituted in clinical *** objective of generic drug development is to develop a stable and bioequivalent generic drug product with desirable properties in a timely *** presentation is intended to summarize three important sequential stages essential for successful generic drug development based on a regulatory experience in reviewing and evaluating the Pharmaceutical development Section(P2)of the ASEAN Common Technical Dossier(ACTD)of generic drug product applications submitted to the Food and drug Administration,Thailand[1,2].

关键词： drug development Generic product Bioequivalent study

Lipid droplets in the nervous system:involvement in cell metabolic homeostasis

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Neural Regeneration Research 2025年第3期20卷 740-750页

作者： Yuchen Zhang Yiqing Chen Cheng Zhuang Jingxuan Qi Robert Chunhua Zhao Jiao Wang School of Life Sciences Shanghai UniversityShanghaiChina School of Medicine Shanghai UniversityShanghaiChina Institute of Basic Medical Sciences Chinese Academy of Medical Sciences School of Basic MedicinePeking Union Medical CollegeBeijingChina Center of Excellence in Tissue Engineering Chinese Academy of Medical SciencesBeijingChina Beijing Key Laboratory of New drug development and Clinical Trial of Stem Cell Therapy BeijingChina

Lipid droplets serve as primary storage organelles for neutral lipids in neurons,glial cells,and other cells in the nervous *** droplet formation begins with the synthesis of neutral lipids in the endoplasmic ***,lipid droplets were recognized for their role in maintaining lipid metabolism and energy homeostasis;however,recent research has shown that lipid droplets are highly adaptive organelles with diverse functions in the nervous *** addition to their role in regulating cell metabolism,lipid droplets play a protective role in various cellular stress ***,lipid droplets exhibit specific functions in neurons and glial *** of lipid droplet formation leads to cellular dysfunction,metabolic abnormalities,and nervous system *** review aims to provide an overview of the role of lipid droplets in the nervous system,covering topics such as biogenesis,cellular specificity,and ***,it will explore the association between lipid droplets and neurodegenerative *** the involvement of lipid droplets in cell metabolic homeostasis related to the nervous system is crucial to determine the underlying causes and in exploring potential therapeutic approaches for these diseases.

关键词： Alzheimer's disease lipid droplet biogenesis lipid droplets lipid metabolism nervous system neurodegenerative disorders oxidative stress Parkinson's disease

Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development

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Acta Pharmaceutica Sinica B 2022年第6期12卷 2751-2777页

作者： Yurong Lai Xiaoyan Chu Li Di Wei Gao Yingying Guo Xingrong Liu Chuang Lu Jialin Mao Hong Shen Huaping Tang Cindy Q.Xia Lei Zhang Xinxin Ding drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA Department of Pharmacokinetics Pharmacodynamics and Drug MetabolismMerck&Co.Inc.KenilworthNJ 07033USA Pharmacokinetics Dynamics and MetabolismPﬁzer Worldwide Research and DevelopmentGrotonCT 06340USA Eli Lilly and Company IndianapolisIN 46221USA drug Metabolism and Pharmacokinetics BiogenCambridgeMA 02142USA drug Metabolism and Pharmacokinetics Accent TherapeuticsInc.LexingtonMA 02421USA Department of drug Metabolism and Pharmacokinetics GenentechA Member of the Roche GroupSouth San FranciscoCA 94080USA drug Metabolism and Pharmacokinetics Department Bristol-Myers Squibb CompanyPrincetonNJ 08540USA Bioanalysis and Biomarkers Glaxo Smith KlineKing of the PrussiaPA 19406USA Department of drug Metabolism and Pharmacokinetics Takeda Pharmaceuticals International Co.CambridgeMA 02139USA Ofﬁce of Research and Standards Ofﬁce of Generic DrugsCDERFDASilver SpringMD 20993USA Department of Pharmacology and Toxicology College of PharmacyUniversity of ArizonaTucsonAZ 85721USA Current afﬁliation:Translational Medicine EMD Serono Research&Development InstituteInc.BillericaMA 01821USA Current afﬁliation:drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA

drug metabolism and pharmacokinetics(DMPK) is an important branch of pharmaceutical *** nature of ADME(absorption,distribution,metabolism,excretion) and PK(pharmacokinetics) inquiries during drug discovery and development has evolved in recent years from being largely descriptive to seeking a more quantitative and mechanistic understanding of the fate of drug candidates in biological *** progress has been made in the past decade,not only in the characterization of physiochemical properties of drugs that influence their ADME,target organ exposure,and toxicity,but also in the identification of design principles that can minimize drug-drug interaction(DDI) potentials and reduce the *** importance of membrane transporters in drug disposition,efficacy,and safety,as well as the interplay with metabolic processes,has been increasingly *** increases in investments on new modalities beyond traditional small and large molecule drugs,such as peptides,oligonucleotides,and antibody-drug conjugates,necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME *** this review,we highlight some of the most notable advances in the last decade,and provide future perspectives on potential major breakthroughs and innovations in the translation of DMPK science in various stages of drug discovery and development.

关键词： drug discovery and development New drug application Biologics license application Pharmacokinetics ADME New modalities Model-informed drug development Micro-physiological systems

Synthesis and Crystal Structure of a 3-Arylamino-3-Deoxy Sugar Derivative

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Chinese Journal of Structural Chemistry 2006年第12期25卷 1492-1496页

作者：姬小明孙贺平莫娟刘宏民 New drug Research & development Center Zhengzhou University

3-Deoxy-3-（p-fluorine-phenylamino）-1,2-O-isopropylidene-α-D-ribofuranose 3 was synthesized and characterized by IR, NMR and H R M S, and its crystal structure was detertnined by X-ray diffraction analysis. Crystal data for 3： monoclinic, space group P21, a=7.0403（14）, b = 6.7780（4）, c = 14.932（3） A, β= 94.74（3）°, C14H18FNO4, Mr = 283.29, V= 710.1（2） A^3, Z = 2, Dc = 1.325 g/cm^3, μ = 0.105 mm^-1, F（000） = 300, the final R = 0.0468 and wR = 0.0926 for 1969 observed reflections （I 〉 2σ（I））. Two intermolecular hydrogen bonds are observed. The absolute configuration of this molecule was confirmed by comparison with that of the original material.

关键词： synthesis crystal structure p-fluorine-phenylamino amino sugar

Transient receptor potential channels and calcium dysregulation: a pathogenic duo in Parkinson's disease

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Neural Regeneration Research 2025年第3期20卷 808-810页

作者： Iqira Saeed Linlin Ma Griffith Institute for drug Discovery Griffith UniversityNathanBrisbaneQLDAustralia School of Environment and Science Griffith University NathanBrisbaneQLDAustralia

Parkinson's disease(PD) has a complex and multifactorial pathophysiology. Various studies, conducted both in pre-clinical models and PD patients, have reported a link between the disruption of calcium(Ca^(2+)) homeostasis and the subsequent development of PD. Ca^(2+) regulation is crucial for neuronal survival, differentiation,exocytosis at synapses,gene transcription,and proliferation.

关键词： homeostasis clinical subsequent

Opportunities and challenges of implementing Pharmacogenomics in cancer drug development

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Cancer drug Resistance 2019年第1期2卷 43-52页

作者： Paolo Tarantino Dario Trapani Stefania Morganti Emanuela Ferraro Giulia Viale Paolo D’Amico Bruno Achutti Duso Giuseppe Curigliano Division of Early drug development for Innovative Therapies IEOEuropean Institute of Oncology IRCCSMilan 20141Italy Department of Oncology and Haematology(DIPO) University of MilanMilan 20122Italy

Cancer drug development is a time and resources consuming *** 90%of drugs entering clinical trials fail due to lack of efficacy and/or safety issues,more often after conspicuous research and economic *** of the discarded drugs might be beneficial only in a subgroup of the study patients,and some adverse events might be prevented by identifying those patients more vulnerable to *** implementation of pharmacogenomic biomarkers allows the categorization of patients,to predict efficacy and toxicity and to optimize the drug development *** seventy FDA approved drugs currently present one or more genetic biomarker to keep in consideration,and with the progress of Precision Medicine tailoring therapies on individuals’genomic landscape promises to become a new standard of cancer *** the current article we review the role of pharmacogenomics in cancer drug development,underlying the advantages and challenges of their implementation.

关键词： Pharmacogenomics cancer drug development precision medicine clinical trials

development and application of hyaluronic acid in tumor targeting drug delivery

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Acta Pharmaceutica Sinica B 2019年第6期9卷 1099-1112页

作者： Zhijian Luo Yan Dai Huile Gao Ultrasound Diagnosis Department of the Affiliated Hospital of Southwest Medical University Southwest Medical UniversityLuzhou 646000China Department of Pharmacy of the Affiliated Hospital of Southwest Medical University Southwest Medical UniversityLuzhou 646000China Key Laboratory of drug Targeting and drug Delivery System of the Education Ministry Sichuan Engineering Laboratory for Plant-Sourced Drug and Sichuan Research Center for Drug Precision Industrial TechnologyWest China School of PharmacySichuan UniversityChengdu 610041China

Hyaluronic acid(HA)is a natural polysaccharide that has gained much attention due to its biocompatibility,enzyme degradation capacity and active tumor targeting *** receptor,CD44,is overexpressed in many kinds of cancers and is associated with tumor progress,infiltration and ***,many researchers have developed various HA-based drug delivery systems for CD44-mediated tumor *** this review,we systemically overview the basic theory of HA,its receptor and hyaluronidase,then we categorize the studies in HA-based drug delivery systems according to the functions of HA,including tumor-targeting materials,enzyme-sensitive biodegradable modality,pHsensitive component,reduction-sensitive component,and the gel ***,the perspective is discussed.

关键词： Hyaluronic acid Tumor-active targeting CD44 Tumor microenvironment Reduction-sensitive Enzyme-sensitive Nanoparticles