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• Kan.1-2. kusa no bu
• kan.3. ki no bu
• kan.4. tori no bu
• kan.5. kemono no bu
• kan.6. mushi no bu
• kan.7. sakana no bu.

• 卷1-2. 草部
• 卷 3. 木部
• 卷 4. 鳥部
• 卷 5. 獣部
• 卷 6. 蟲部
• 卷 7. 魚部.

二〇一二年底, 成都文物考古研究院抢救性发掘了的成都市金牛 区天回镇的一处西汉墓, 墓中出土了一批以医书为主的竹简.为了尽早让更 多专家学者和广大书法爱好者了解这批两千多年 前的医书真迹, 我们挑选了天回医简几种医书中保存情况尚佳, 且能代表其中不同书写风格的简, 汇编为一册, 以飨读者.在原大的彩色照片旁, 我们提供了该枚简的红外扫描放大图片, 以期最大限度地呈现竹书字迹的细节, 使古代书手的笔法清晰展现于读者面前.所附释文 尽可能依照原简字形隶定, 保留重文及句读符号, 不加括注.天回镇成都天回医简中的书体大致有:" 疗马书"中的篆隶, "脉书, 上经""[ba]理""脉书, 下经""治六十病合齐汤法"中的古隶, 以及"逆顺五色脉臧验精神""刺数"中较为接近八分 书的隶书.就目前出土的简帛文字情况看, 像天回医简这样, 在同一墓葬中兼见篆隶, 古隶及八分三种字体的竹简, 是较为少见的.可以说, 天回医简中的字体变迁, 是秦汉之际汉字隶变的缩影, 为我们研究秦汉时期字形演变提供了宝贵的一手 材料.由于"经脉""律令遗文"两篇文字残损较为严 重, 本书法集未将此二书的竹简编入. 二〇一二年底, 成都文物考古研究院抢救性发掘了的成都市金牛 区天回镇的一处西汉墓, 墓中出土了一批以医书为主的竹简.为了尽早让更 多专家学者和广大书法爱好者了解这批两千多年 前的医书真迹, 我们挑选了天回医简几种医书中保存情况尚佳, 且能代表其中不同书写风格的简, 汇编为一册, 以飨读者.在原大的彩色照片旁, 我们提供了该枚简的红外扫描放大图片, 以期最大限度地呈现竹书字迹的细节, 使古代书手的笔法清晰展现于读者面前.所附释文 尽可能依照原简字形隶定, 保留重文及句读符号, 不加括注.天回镇成都天回医简中的书体大致有:" 疗马书"中的篆隶, "脉书, 上经""[ba]理""脉书, 下经""治六十病合齐汤法"中的古隶, 以及"逆顺五色脉臧验精神""刺数"中较为接近八分 书的隶书.就目前出土的简帛文字情况看, 像天回医简这样, 在同一墓葬中兼见篆隶, 古隶及八分三种字体的竹简, 是较为少见的.可以说, 天回医简中的字体变迁, 是秦汉之际汉字隶变的缩影, 为我们研究秦汉时期字形演变提供了宝贵的一手 材料.由于"经脉""律令遗文"两篇文字残损较为严 重, 本书法集未将此二书的竹简编入.

• Biopharmaceutical Landscape
• Regulatory Pathways Impacting Biopharmaceuticals
• Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
• Risk Management of the Minimum CMC Regulatory Compliance Continuum
• Ever-Present Threat of Adventitious Agent Contamination
• Starting Materials for Manufacturing the Biopharmaceutical Drug Substance
• Upstream Production of the Biopharmaceutical Drug Substance
• Downstream Purification of the Biopharmaceutical Drug Substance
• Manufacturing the Biopharmaceutical Drug Product
• Complex Process-Related Impurity Profiles
• Seemingly Endless Biomolecular Structural Variants
• Indispensable Potency (Biological Activity)
• Biopharmaceutical Critical Quality Attributes
• The Art of Setting Biopharmaceutical Specifications ⁰́₃ Release and Shelf-Life
• The Challenge of Demonstrating Biopharmaceutical Product Comparability
• Strategic CMC-Focused Interactions with Regulatory Authorities

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals

• Intro
• Foreword to the First Edition
• Preface to the Second Edition
• Preface to the First Edition
• Explanatory Notes
• Abbreviations
• Language
• Technical
• Literature References
• BOOKS (Classical Ayurvedic Texts)
• BOOKS and REPORTS
• Contents
• Section-I GENERAL INTRODUCTION
• GENERAL INTRODUCTION
• 1. Ayurveda
• 1.1 Introduction
• 1.2 Concepts
• Tridosha
• Drug Action
• 1.3 Diseases
• Gulma (Gaseous lumps in the abdomen)
• Hrdroga (Heart diseases)
• Jvara (Fever)
• Krimi (Parasites)
• Kustha (Skin diseases including leprosy)
• Medoroga (Lipid disorders)

• Meha/Prameha (Obstinate urinary disorders)
• Rakta pitta (Haemorrhagic disorders)
• Visarpa (Cellulitis)
• 1.4 Medicinal Plants
• Classification of Medicinal Plants
• 2. Modern Evaluation of Ayurvedic Plant Drugs
• 2.1 Curative Plant Drugs
• Psoralea corylifolia Linn. (Baakuchi)
• Rauvolfia serpentina Benth. ex Kurz (Sarpagandhaa)
• Cedrus Deodara (Roxb. ex Lamb.) G. Don (Devadaaru)
• Commiphora wightii (Arnott.) Bhandari (Guggulu)
• 2.2 Health Supporting Plant Drugs
• Antiageing (Vayahsthaapana) Drugs
• Ageing
• Oxidative Stress and Ageing
• Asparagus racemosus Willd. (Shataavari)

• Boerhavia diffusa Linn. (Punarnavaa)
• Centella asiatica (Linn.) Urban. (Mandookaparni)
• Clitoria ternatea Linn. (Apraajitaa)
• Desmodium gangeticum (Linn.) DC. (Shaalparni)
• Emblica officinalis Gaertn. (Aamalaki)
• Leptadenia reticulata (Retz.) Wt. and Arn. (Jeevanti)
• Pluchea lanceolata (DC.) Clarke (Raasnaa)
• Terminalia chebula Retz. (Haritaki)
• Tinospora cordifolia (Willd.) Hook. f. and Thoms. (Guduchi)
• Conclusion
• 3. Ethnotherapeutics and Modern Drug Development
• 3.1 Molecular Drugs
• Higher Plant Drugs and the Role of Ethnotherapeutics
• Role of Ethnotherapeutics

• 3.2 Phytopharmaceuticals
• Herbs with Several Actives
• Curcuma longa Linn.
• Curcuma zeodory (Berg.) Rosc.
• Glycyrrhiza glabra
• Tinospora cordifolia (Willd.) Miers ex Hook. f. & Thoms.
• Zingiber officinale Rosc.
• Herbs with Synergistic Interactions of Constituents
• Artemisia annua Linn.
• Berberis spp.
• Cassia angustifolia Vahl.
• Commiphora wightii (Arnott.) Bhandari
• Curcuma longa Linn.
• Herbal-Herbal Interactions and Adjuvant Therapy
• Bioavailability Enhancers
• Disabling Infection/Disease Resistance
• Fortifying Immune Defence
• Comments
• References

• Section-II Monographs
• 1 Abies spectabilis (D. Don) Spach
• Plant
• Chemical Constituents
• Therapeutic Uses
• New Findings
• Toxicity
• References
• 2 Acacia catechu Willd.
• Plant
• Chemical Constituents
• Therapeutic Uses
• Modern Scientific Validation
• New Findings
• Toxicity
• References
• 3 Achyranthes aspera Linn.
• Plant
• Chemical Constituents
• Therapeutic Uses
• Modern Scientific Validation
• New Findings
• Toxicity
• References
• 4 Acorus calamus Linn.
• Plant
• Chemical Constituents
• Therapeutic Uses
• New Findings
• Toxicity
• References

This handbook covers the medicinal and chemical properties of Ayurvedic medicines, the plants that produce them and the currently known organic compounds that occur therein. It provides therapeutic attributes of each plant as well as indicates its potential for use as modern herbal or molecular drug. It combines the works of Ayurvedic folk medicine with modern pharmacology, botany, and chemistry in a singularly effective way. It also provides a useful standardization of classical Ayurvedic formulations. Consisting of numerous photographs of medicinal plants, this handbook will serve as an excellent reference work for chemists, botanists, pharmacists, and medical professionals

At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills

• 1. Pak Ssi ka ŭi pyŏngyŏng chinch'ul kwa Pak Yakkuk kyŏngyŏng
• 2. Maeip changbu rŭl t'onghae pon Pak Yakkuk ŭi yakchae maeip silt'ae
• 3. P'anmae changbu rŭl t'onghae pon Pak Yakkuk ŭi ŭiyak kŏrae kwanhaeng
• 4. Pak Yakkuk ŭi kogaek kwalli wa kyŏngyŏng chŏllyak
• 5. Pak Yakkuk p'anmae ŭiyak ŭl t'onghae pon yakkap kwa chilbyŏng
• 6. Pak Yakkuk changbu rŭl t'onghae pon hwan sayong silt'ae wa mek'ŏnijŭm

• 1. 박 씨 가 의 병영 진출 과 박 약국 경영
• 2. 매입 장부 를 통해 본 박 약국 의 약재 매입 실태
• 3. 판매 장부 를 통해 본 박 약국 의 의약 거래 관행
• 4. 박 약국 의 고객 관리 와 경영 전략
• 5. 박 약국 판매 의약 을 통해 본 약값 과 질병
• 6. 박 약국 장부 를 통해 본 환 (煥) 사용 실태 와 메커니즘.

• Antibody-Drug Conjugates Basic Concepts and Structures
• Relationship between target and specific action of antibody-drugs conjugates
• The internalization and therapeutic activity of antibody drug conjugate
• The internalization and intracellular trafficking of ADC
• Distribution and metabolism of antibody-drug conjugates
• Application of Antibody fragments in ADCs
• Novel Targeting Carriers in Antibody-drug Conjugates
• Site-specified Conjugating Technology and Application
• Determination of drug-to-antibody ratio of ADCs
• Pharmacokinetic study of antibody-drug conjugates.

This book summarizes the related research achievements in Antibody-drug conjugates (ADCs) and their cell metabolism kinetics. The book has three main parts. The first part describes the basic theory of ADCs, including the basic concept and structure of ADCs, and the relationship between the targets of ADCs and their specific functions. The second part mainly introduces the endocytosis and intracellular metabolism of ADCs, including the relationship between endocytosis and ADC activity, the endocytosis and intracellular transport of ADCs, the distribution and metabolism of ADC in vivo. Then it discusses the new formats and research technology of ADCs, including the application of miniaturized antibodies in ADC synthesis, novel carriers for ADC design, the technology and application of site-specific conjugation, and approaches for analyzing the drug: antibody ratio (DAR), the study of pharmacokinetics of ADCs. This book combines the basic theory with the research technology. It can be used as a reference book for students, teachers and researchers of biomedical field.

• 1. Conducting polymers as drug release systems
• 2. Electrospinning for drug delivery applications
• 3. Melt-electrospinning and electrowriting for pharmaceutical and biomedical applications
• 4. Pharmaceutical Spray Drying
• 5. Vat photopolymerization 3D printing for drug delivery applications
• 6. Semi-solid extrusion 3D printing for the development of dosage forms for special patient groups
• 7. Binder-Jetting Powder bed 3Dprinting for the fabrication of drug delivery systems
• 8. 3D printing for localized cancer therapy
• 9. 4D Printing in Pharmaceutics & Biomedical Applications
• 10. Lithography in Drug-Delivery
• 11. Micro-moulding and its application to drug delivery
• 12. Supercritical Fluids: A Promising Technique in Pharmaceutics
• 13. Microfluidics as a tool for the synthesis of advanced drug delivery systems
• 14. Nanofluidic Technologies for Drug Screening and Drug Delivery
• 15. Nanoparticles at the stage of clinical trials
• 16. Nasal drug delivery systems for the treatment of diseases of the central nervous system and tuberculosis
• 17. Regulatory aspects and barriers in using ground-breaking technologies. .

New materials and manufacturing techniques are evolving with the potential to address the challenges associated with the manufacture of medicinal products that will teach new tricks to old drugs. Nano- and microfabrication techniques include manufacturing methods such as additive manufacturing, lithography, micro-moulding, spray drying, and supercritical fluids among many others. The increasing resolution of new techniques allow researchers to produce objects with micrometric resolutions. This book follows a consecutive order, beginning with a background in the current field and limitations in the manufacturing of different pharmaceutical products, moving on the classification of each method by providing recent examples, and future prospective on a variety of traditional and new Nano and microfabrication techniques. A focus on the materials used to prepare these systems and their biocompatibility, including applied topics such as clinical applications and regulatory aspects also covered, offering the reader a holistic view of this rapidly growing field.

• Overview of Freeze Drying
• Characterization and Determination of Freeze Drying Properties of Frozen Formulations Case Studies
• Beyond pH: Acid/base relationships in frozen and freeze-dried pharmaceuticals
• Concepts and Strategies in the Design of Formulation for Freeze Drying
• Formulation Design for Freeze Drying - Case studies of Stabilization of Proteins
• Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product
• Freeze-drying of thermosensible pharmaceuticals with organic co-solvent + water formulations
• Primary container closure system selection for lyophilized drug products
• Vial Breakage During Lyophilization
• The Nucleation of Ice
• Stresses, Stabilization, and Recent Insights in Freezing of Biologics
• Lyophilization Process Understanding and Scale-up using ab initio Vial Heat Transfer Modeling
• Secondary drying: Challenges and Considerations
• Design and Process Considerations in Spray Freeze Drying
• LyoPRONTO: Deterministic and Probabilistic Modeling. Tutorial and Case Study
• Utilizing Solid-State NMR Spectroscopy to Assess Properties of Lyophilized Formulations
• Design of Moisture Studies for a Lyophilized Product
• Laser-Based Headspace Moisture Analysis for Rapid Nondestructive Moisture Determination of Lyophilized Products
• Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process
• Process Analytical Technology (PAT) for Lyophilization Process Monitoring and End Point Detection
• Advances in Process Analytical Technology A Small Scale Freeze-Dryer for Process Analysis, Optimization, and Transfer
• Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Tool (PAT) Capability
• Application of QbD elements in the Development and Manufacturing of a Lyophilized product
• Characterization of Freeze Dryer
• Scale-up and Technology Transfer of a Lyophilization Process
• Lyophilization Validation: Process Design and Modeling
• Lyophilization Validation: Process Qualification and Continued Process Verification
• Homogeneity Assessment of Lyohilized Biological Drug Products During Process Performance Qualification
• Informed Manufacturing through the use of Big Data Analytics for Freeze Drying Process & Equipment
• Multivariate Analysis for Process Understanding, Continuous Process Verification and Condition Monitoring of Lyophilization Processes
• Lyophilized Drug Product Cake Appearance: What Is Acceptable?.

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing, starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on Preservation of Biologicals comprised of nine chapters written by experts and including case studies.

Since their clinical use initiation in the 1970's, Fluorine-18 (F-18) radiopharmaceuticals continue to play an important role in nuclear medicine. It is therefore essential to make available broad information on practical production routes and optimal quality control for F-18 tracers, to achieve the best possible products in high quantity and quality for clinical applications while fulfilling all regulatory requirements. This publication describes the chemical and biological properties of F-18 radiopharmaceuticals. This includes aspects relating to F-18 target production and radiofluorination methods, with focus on the applied techniques. The publication presents a disease oriented approach, describing F-18 radiopharmaceuticals, ranging from the physiological/biological aspects to dedicated radiopharmaceutical development approaches and provides readers with clear guidelines and methods for the production of F-18 radiopharmaceuticals.