Quantitative Methods In Pharmaceutical Research And Development

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Quantitative Methods in Pharmaceutical Research and Development

Author : Olga V. Marchenko
Publisher : Springer Nature
ISBN 13 : 3030485552
Total Pages : 445 pages
Book Rating : 4.0/5 (34 download)

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Book Synopsis Quantitative Methods in Pharmaceutical Research and Development by : Olga V. Marchenko

Download or read book Quantitative Methods in Pharmaceutical Research and Development written by Olga V. Marchenko and published by Springer Nature. This book was released on 2020-09-24 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and marketing. Chapters bring together the theories and applications of various disciplines, allowing readers to learn more about quantitative fields, and to better recognize the differences between them. Because it provides a thorough overview, this will serve as a self-contained resource for readers interested in the pharmaceutical industry, and the quantitative methods that serve as its foundation. Specific disciplines covered include: Biostatistics Pharmacometrics Genomics Bioinformatics Pharmacoepidemiology Commercial analytics Operational analytics Quantitative Methods in Pharmaceutical Research and Development is ideal for undergraduate students interested in learning about real-world applications of quantitative methods, and the potential career options open to them. It will also be of interest to experts working in these areas.

Drug Design Strategies

Author : David J. Livingstone
Publisher : Royal Society of Chemistry
ISBN 13 : 1849731667
Total Pages : 517 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Drug Design Strategies by : David J. Livingstone

Download or read book Drug Design Strategies written by David J. Livingstone and published by Royal Society of Chemistry. This book was released on 2012 with total page 517 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together drug design practitioners, all leaders in their field, who are actively advancing the field of quantitative methods to guide drug discovery, from structure-based design to empirical statistical models - from rule-based approaches to toxicology to the fields of bioinformatics and systems biology. The aim of the book is to show how various facets of the drug discovery process can be addressed in a quantitative fashion (ie: numerical analysis to enable robust predictions to be made). Each chapter includes a brief review of the topic showing the historical development of.

Statistical Development of Quality in Medicine

Author : Per Winkel
Publisher : John Wiley & Sons
ISBN 13 : 9780470515891
Total Pages : 280 pages
Book Rating : 4.5/5 (158 download)

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Book Synopsis Statistical Development of Quality in Medicine by : Per Winkel

Download or read book Statistical Development of Quality in Medicine written by Per Winkel and published by John Wiley & Sons. This book was released on 2007-06-13 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: The promotion of standards and guidelines to advance quality assurance and control is an integral part of the health care sector. Quantitative methods are needed to monitor, control and improve the quality of medical processes. Statistical Development of Quality in Medicine presents the statistical concepts behind the application of industrial quality control methods. Filled with numerous case studies and worked examples, the text enables the reader to choose the relevant control chart, to critically apply it, improve it if necessary, and monitor its stability. Furthermore, the reader is provided with the necessary background to critically assess the literature on the application of control charts and risk adjustment and to apply the findings. Contains a user-friendly introduction, setting out the necessary statistical concepts used in the field. Uses numerous real-life case studies from the literature and the authors’ own research as the backbone of the text. Provides a supplementary website featuring problems and answers drawn from the book, alongside examples in Statgraphics. The accessible style of Statistical Development of in Clinical Medicine invites a large readership. It is primarily aimed at health care officials, and personnel responsible for developing and controlling the quality of health care services. However, it is also ideal for statisticians working with health care problems, diagnostic and pharmaceutical companies, and graduate students of quality control.

Statistical Methods for Pharmaceutical Research Planning

Author : S. W. Bergman
Publisher : CRC Press
ISBN 13 : 1000148734
Total Pages : 273 pages
Book Rating : 4.0/5 (1 download)

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Book Synopsis Statistical Methods for Pharmaceutical Research Planning by : S. W. Bergman

Download or read book Statistical Methods for Pharmaceutical Research Planning written by S. W. Bergman and published by CRC Press. This book was released on 2020-10-29 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on statistical methods which impinge more or less directly on the decisions that are made during the course of pharmaceutical and agro-chemical research, considering the four decision-making areas.

Research Methods in Pharmacy Practice

Author : Zubin Austin
Publisher : Elsevier Health Sciences
ISBN 13 : 070207425X
Total Pages : 280 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Research Methods in Pharmacy Practice by : Zubin Austin

Download or read book Research Methods in Pharmacy Practice written by Zubin Austin and published by Elsevier Health Sciences. This book was released on 2018-02-21 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive guide to applying research methods to practice problems. It uses case-based examples and activities rooted in practice to support development of knowledge, skills, and confidence in applying evidence-based research methods. An array of different methodologies and qualitative/quantitative methods are described. Examples of topics include distinction between methodologies and methods, ethics protocols, as well as design/implementation/data analysis/interpretation of findings using methods such as surveys, interviews, focus groups, observational research, database mining, text and document analysis, quality improvement (PDSA cycles), economic (cost/benefit) evaluations. Perfect for MPharm students doing their research thesis, but relevant to all bioscience students undertaking research projects. Use of pharmacy practice case examples (in community, hospital, ambulatory, primary care and other settings) throughout. Examples of how to tackle a research question from different perspectives, e.g. which is the best way to answer each question and why. Inter-professional practice and research emphasized. Self-assessment and self-reflection questions to help readers confirm their understanding/learning. A one-stop research-method teaching resource for faculty.

Quantitative Methods in System-Based Drug Discovery

Author : Yuzhen Luo
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (115 download)

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Book Synopsis Quantitative Methods in System-Based Drug Discovery by : Yuzhen Luo

Download or read book Quantitative Methods in System-Based Drug Discovery written by Yuzhen Luo and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern pharmaceutical industries have faced significant challenges to deliver safe and effective medicines because of significant toxicity and severe side effects of discovered drugs. On the other hand, recent developments and advances in system-based pharmacology aim to address these challenges. In this chapter, we provide an overview of quantitative methods for system-based drug discovery. System-based drug discovery integrates chemical, molecular, and systematic information and applies this knowledge to the designing of small molecules with controlled toxicity and minimized side effects. First, we discuss current approaches for drug discovery and outline their advantages and disadvantages. Next, we introduce basic concepts of systems pharmacology with an emphasis on ligand-based drug discovery and target identification. This is followed by a discussion on structure-based drug design and statistical tools for pharmaceutical research. Finally, we provide an overview of future directions in systems pharmacology that will guide further developments.

Computer Applications in Pharmaceutical Research and Development

Author : Sean Ekins
Publisher : John Wiley & Sons
ISBN 13 : 0470037229
Total Pages : 840 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Computer Applications in Pharmaceutical Research and Development by : Sean Ekins

Download or read book Computer Applications in Pharmaceutical Research and Development written by Sean Ekins and published by John Wiley & Sons. This book was released on 2006-07-11 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique, holistic approach covering all functions and phases of pharmaceutical research and development While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. Chapters are organized into the following sections: * Computers in pharmaceutical research and development: a general overview * Understanding diseases: mining complex systems for knowledge * Scientific information handling and enhancing productivity * Computers in drug discovery * Computers in preclinical development * Computers in development decision making, economics, and market analysis * Computers in clinical development * Future applications and future development Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

Quantitative Calculations in Pharmaceutical Practice and Research

Author : Themistoklēs P. Chatzēiōannou
Publisher : VCH Publishers
ISBN 13 :
Total Pages : 488 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Quantitative Calculations in Pharmaceutical Practice and Research by : Themistoklēs P. Chatzēiōannou

Download or read book Quantitative Calculations in Pharmaceutical Practice and Research written by Themistoklēs P. Chatzēiōannou and published by VCH Publishers. This book was released on 1993 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical handbook aims at familiarizing students and scientists with the most common calculations encountered in the pharmaceutical sciences. It consolidates theoretical knowledge by applying it to the solution of real problems. Each chapter provides a short introduction of the relevant theory and includes equations to aid the comprehension of the theoretical principle. The text includes 220 solved examples and 250 problems and answers. Annotation copyright by Book News, Inc., Portland, OR

Quantitative Analysis of Cellular Drug Transport, Disposition, and Delivery

Author : Gus R. Rosania
Publisher : Humana
ISBN 13 : 9781071612491
Total Pages : 453 pages
Book Rating : 4.6/5 (124 download)

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Book Synopsis Quantitative Analysis of Cellular Drug Transport, Disposition, and Delivery by : Gus R. Rosania

Download or read book Quantitative Analysis of Cellular Drug Transport, Disposition, and Delivery written by Gus R. Rosania and published by Humana. This book was released on 2021-07-12 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: This thorough book explores some of the most important methods and concepts affecting the quantitative analysis of the transport, targeting, and disposition of chemicals within cells, which in turn impact the macroscopic pharmacokinetics of chemical agents in the whole organism. The first half of the volume focuses on small organic molecules with drug-like characteristics, while the second half delves into the cellular pharmacokinetics of biologics and other macromolecules, including peptide therapeutics, cyclotides, antibodies, as well as nanoparticles, thus creating a comprehensive treatise that approaches cellular pharmacokinetics from the different perspectives of pharmaceutical scientists, chemical biologists, medicinal chemists, and protein engineers dealing with very different chemical agents spanning a wide range of sizes, physicochemical properties, and targeting mechanisms. Written for the Methods in Pharmacology and Toxicology series, chapters provide the kind of key detail and expert implementation advice that leads to excellent results in the lab. Synthetic biologists, biophysicists, and bioengineers are amongst the long list of scientists who could benefit from reading this book or from using it as a textbook. Authoritative and practical, Quantitative Analysis of Cellular Drug Transport, Disposition, and Delivery builds on a long history of drug development and the adding of quantitative methods at the cellular scale in order to inspire new approaches to drug development that are better able to take advantage of phenomena such as soluble-to-insoluble phase transitions or bispecific targeting, which could ultimately be exploited for the development of more effective drug delivery systems and therapeutic agents.

Pharmaceutical Statistics

Author : Ray Liu
Publisher : Springer
ISBN 13 : 3319673866
Total Pages : 337 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Pharmaceutical Statistics by : Ray Liu

Download or read book Pharmaceutical Statistics written by Ray Liu and published by Springer. This book was released on 2019-06-12 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D – with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R&D for almost forty years, with the 2016 conference theme being “The Power and 3 I’s of Statistics: Innovation, Impact and Integrity.” The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and development, including pharmaceutical statisticians who want to keep up-to-date with the latest trends, as well as academic statistics researchers looking for areas of application.

Quantitative Evaluation of Safety in Drug Development

Author : Qi Jiang
Publisher : CRC Press
ISBN 13 : 1466555459
Total Pages : 386 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Quantitative Evaluation of Safety in Drug Development by : Qi Jiang

Download or read book Quantitative Evaluation of Safety in Drug Development written by Qi Jiang and published by CRC Press. This book was released on 2014-12-08 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book’s three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Pharmaceutical Analysis

Author : David C Lee
Publisher : John Wiley & Sons
ISBN 13 : 1405172991
Total Pages : 384 pages
Book Rating : 4.4/5 (51 download)

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Book Synopsis Pharmaceutical Analysis by : David C Lee

Download or read book Pharmaceutical Analysis written by David C Lee and published by John Wiley & Sons. This book was released on 2009-02-12 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.

Benefit-Risk Assessment in Pharmaceutical Research and Development

Author : Andreas Sashegyi
Publisher : CRC Press
ISBN 13 : 1439867941
Total Pages : 222 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Benefit-Risk Assessment in Pharmaceutical Research and Development by : Andreas Sashegyi

Download or read book Benefit-Risk Assessment in Pharmaceutical Research and Development written by Andreas Sashegyi and published by CRC Press. This book was released on 2013-11-27 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment. The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule’s journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule’s entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety. Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.

Quantitative Methods for Traditional Chinese Medicine Development

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1482236001
Total Pages : 433 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Quantitative Methods for Traditional Chinese Medicine Development by : Shein-Chung Chow

Download or read book Quantitative Methods for Traditional Chinese Medicine Development written by Shein-Chung Chow and published by CRC Press. This book was released on 2015-10-15 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world's most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency

Colloid and Interface Science in Pharmaceutical Research and Development

Author : Hiroyuki Ohshima
Publisher : Elsevier
ISBN 13 : 0444626085
Total Pages : 533 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis Colloid and Interface Science in Pharmaceutical Research and Development by : Hiroyuki Ohshima

Download or read book Colloid and Interface Science in Pharmaceutical Research and Development written by Hiroyuki Ohshima and published by Elsevier. This book was released on 2014-07-23 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: Colloid and Interface Science in Pharmaceutical Research and Development describes the role of colloid and surface chemistry in the pharmaceutical sciences. It gives a detailed account of colloid theory, and explains physicochemical properties of the colloidal-pharmaceutical systems, and the methods for their measurement. The book starts with fundamentals in Part I, covering fundamental aspects of colloid and interface sciences as applied to pharmaceutical sciences and thus should be suitable for teaching. Parts II and III treat applications and measurements, and they explains the application of these properties and their influence and use for the development of new drugs. - Provides a clear description of the fundamentals of colloid and interface science relevant to drug research and development - Explains the physicochemical/colloidal basis of pharmaceutical science - Lists modern experimental characterization techniques, provides analytical equations and explanations on analyzing the experimental data - Describes the most advanced techniques, AFM (Atomic Force Microscopy), SFA (Surface Force Apparatus) in detail

Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
ISBN 13 : 9780470723579
Total Pages : 523 pages
Book Rating : 4.7/5 (235 download)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2008-02-28 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Comparative Analysis and Benchmarking

Author : Hung-hsin Chen
Publisher : Universal-Publishers
ISBN 13 : 158112189X
Total Pages : 138 pages
Book Rating : 4.5/5 (811 download)

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Book Synopsis Comparative Analysis and Benchmarking by : Hung-hsin Chen

Download or read book Comparative Analysis and Benchmarking written by Hung-hsin Chen and published by Universal-Publishers. This book was released on 2003 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This research of corporate strategy analysis implements comparative analysis and benchmarking to analyse and examine the corporate strategy of the pharmaceutical sectors of 4 international pharmaceutical companies. This research adopts the hybrid approach of combining qualitative and quantitative methods in a two stages research design. Quantitative method is applied first to deal with the comparative figures, and then qualitative method is used to find out the problem. The design of this multiple research includes three phases: data collection, analysis, and reporting. The findings of this research can be divided into 4 parts: R&D/marketing, technology alliances, strategic acquisitions and merger, and manufacturing. The drug innovative projects are recommended being developed within the company's familiar therapeutic areas in order to take its marketing advantage. Through this comparative analysis, some of this type of problems of these international pharmaceutical companies is identified. A big pharmaceutical company forming alliances with some small biotechnology companies has become a trend within pharmaceutical industry since 1980s. For pharmaceutical companies, to take advantage of R&D through biotechnology is the main purpose of alliances with small biotechnology companies. It is important to note that most pharmaceutical acquisitions belong to the type of absorption with high resource transferring and low autonomy. Due to the high profit margin and the essential importance of R&D and marketing, the operation management of manufacturing of pharmaceutical industry is relatively poor. The low asset utilisation rate pointed out this problem. Academic researches have revealed that existing theories of operation management of manufacturing, such as action research, set-up reduction, teamwork, continuous improvement, collaboration, and involvement, are applicable and beneficial to pharmaceutical industry rather than waiting for the technology breakthroughs.