Swarbrick.J. - Encyclopedia of Pharmaceutical Technology v.1.pdf - ANGIELSKIE - chomik.gumppka

Volume 1

21 CFR Part 11 Revisited / 1

Absorption Enhancers / 13

Absorption of Drugs / 19

Adsorption at Solid Surfaces: Pharmaceutical Applications / 34

Adverse Drug Reactions / 46

Advertising and Promotion of Prescription and Over-the-Counter

Drug Products / 57

Alternative Medicines / 66

Amorphous Pharmaceutical Systems / 83

Analytical Procedures: Validation / 92

Animals in Drug Development / 114

Aseptic Processing: Validation / 127

Autoxidation and Antioxidants / 139

Bioabsorbable Polymers / 155

Bioavailability of Drugs and Bioequivalence / 164

Biodegradable Polymers as Drug Carriers / 176

Biologic Fluids: Analysis / 194

Biopharmaceutics / 208

Biosynthesis of Drugs / 228

Biotechnology and Biological Preparations / 258

Biotechnology-Derived Drug Products: Formulation Development / 281

Biotechnology-Derived Drug Products: Stability Testing,

Filling, and Packaging / 302

Biotransformation of Drugs / 310

Bio-Validation of Steam Sterilization / 325

Blood Substitutes: Fluorocarbon Approach / 335

Blood Substitutes: Hemoglobin-Based Oxygen Carriers / 353

Blow-Fill-Seal: Advanced Aseptic Processing / 378

Buffers, Buffering Agents, and Ionic Equilibria / 385

Calorimetry in Pharmaceutical Research and Development / 393

Capsules, Hard / 406

Capsules, Soft / 419

Carcinogenicity Testing: Past, Present, and Future / 431

Chiroptical Analytical Methods / 445

Chromatographic Methods of Analysis: Gas Chromatography / 463

Chromatographic Methods of Analysis: High Performance Liquid

Chromatography / 526

Chromatographic Methods of Analysis: Thin Layer Chromatography / 538

Clinical Data Management Systems / 551

Clinical Evaluation of Drugs / 560

Clinical Pharmacokinetics and Pharmacodynamics / 572

Clinical Supplies Manufacture: GMP Considerations / 591

Coacervation and Phase Separation / 600

Cocrystals: Design, Properties and Formation Mechanisms / 615

Colloids and Colloid Drug Delivery System / 636

Coloring Agents for Use in Pharmaceuticals / 648

Volume 2 ( Continued )

Drug Delivery: Liquid Crystals in / 1115

Drug Delivery: Monoclonal Antibodies / 1132

Drug Delivery: Monoclonal Antibodies in Imaging and Therapy / 1149

Drug Delivery: Mucoadhesive Hydrogels / 1169

Drug Delivery: Nanoparticles / 1183

Drug Delivery: Nasal Route / 1201

Drug Delivery: Needle-Free Systems / 1209

Drug Delivery: Ophthalmic Route / 1220

Drug Delivery: Oral Colon-Speciﬁc / 1228

Drug Delivery: Oral Route / 1242

Drug Delivery: Parenteral Route / 1266

Drug Delivery: Pulmonary Delivery / 1279

Drug Delivery: Pulsatile Systems / 1287

Drug Delivery: Rectal Route / 1298

Drug Delivery: Topical and Transdermal Routes / 1311

Drug Delivery: Tumor-Targeted Systems / 1326

Drug Delivery: Vaginal Route / 1339

Drug Design: Basic Principles and Applications / 1362

Drug Development Management / 1370

Drug Information Systems / 1385

Drug Interactions / 1392

Drug Master Files / 1401

Drug Safety Evaluation / 1406

Dry Powder Aerosols: Emerging Technologies / 1428

Volume 3

Drying and Dryers / 1435

Economic Characteristics of the R&D Intensive Pharmaceutical

Industry / 1450

Effervescent Pharmaceuticals / 1454

Elastomeric Components for the Pharmaceutical Industry / 1466

Electrical Power Systems for Pharmaceutical Equipment / 1482

Electroanalytical Methods of Analysis: Polarography and Voltammetry / 1490

Electroanalytical Methods of Analysis: Potentiometry / 1502

Electrochemical Detection for Pharmaceutical Analysis / 1516

Electrostatic Charge in Pharmaceutical Systems / 1535

Emulsions and Microemulsions / 1548

Enzyme Immunoassay and Related Bioanalytical Methods / 1566

Equipment Cleaning / 1580

European Agency for the Evaluation of Medicinal Products (EMEA) / 1593

Evaporation and Evaporators / 1600

Excipients for Pharmaceutical Dosage Forms / 1609

Excipients: Parenteral Dosage Forms and Their Role / 1622

Excipients: Powders and Solid Dosage Forms / 1646

Excipients: Safety Testing / 1656

Expert Systems in Pharmaceutical Product Development / 1663

Expiration Dating / 1685

Extractables and Leachables in Drugs and Packaging / 1693

Extrusion and Extruders / 1712

Film Coating of Oral Solid Dosage Forms / 1729

Filters and Filtration / 1748

Flame Photometry / 1759

Flavors and Flavor Modiﬁers / 1763

Fluid Bed Processes for Forming Functional Particles / 1773

Food and Drug Administration: Role in Drug Regulation / 1779

Fractal Geometry in Pharmaceutical and Biological Applications / 1791

Freeze Drying / 1807

Freeze Drying, Scale-Up Considerations / 1834

Gastro-Retentive Systems / 1850

Gelatin-Containing Formulations: Changes in Dissolution

Characteristics / 1861

Gels and Jellies / 1875

Generic Drugs and Generic Equivalency / 1891

Genetic Aspects of Drug Development / 1897

Geriatric Dosing and Dosage Forms / 1905

Good Clinical Practices (GCPs): An Overview / 1925

Good Laboratory Practices (GLPs): An Overview / 1931

Good Manufacturing Practices (GMPs): An Overview / 1941

Handling Hazardous Chemicals and Pharmaceuticals / 1948

Harmonization of Pharmacopeial Standards / 1955

Headspace Oxygen Analysis in Pharmaceutical Products / 1967

Health Care Systems: Outside the United States / 1977

Health Care Systems: Within the United States / 1985

Homogenization and Homogenizers / 1996

Hot-Melt Extrusion Technology / 2004

Hydrogels / 2021

Hydrolysis of Drugs / 2040

Immunoassay / 2048

In Vitro–In Vivo Correlation / 2062

Inhalation: Dry Powder / 2077

Inhalation: Liquids / 2092

Volume 2

Complexation: Cyclodextrins / 671

Complexation: Non-Cyclodextrins / 697

Computer Systems Validation / 707

Computer-Assisted Drug Design / 714

Computers in Pharmaceutical Technology / 732

Continuous Processing of Pharmaceuticals / 743

Contract Manufacturing / 750

Cooling Processes and Congealing / 761

Coprecipitates and Melts / 774

Corrosion of Pharmaceutical Equipment / 782

Cosmetics and Their Relation to Drugs / 798

Cosolvents and Cosolvency / 806

Crystal Habit Changes and Dosage Form Performance / 820

Crystallization: General Principles and Signiﬁcance on Product

Development / 834

Crystallization: Particle Size Control / 858

Dendrimers / 872

Dental Products / 891

Dissolution and Dissolution Testing / 908

DNA Probes for the Identiﬁcation of Microbes / 929

Dosage Form Design: A Physicochemical Approach / 939

Dosage Forms and Basic Preparations: History / 948

Dosage Forms: Lipid Excipients / 975

Dosage Forms: Non-Parenterals / 988

Dosage Forms: Parenterals / 1001

Dosage Regimens and Dose-Response / 1012

Dressings in Wound Management / 1023

Drug Abuse / 1038

Drug Delivery Systems: Neutron Scattering Studies / 1049

Drug Delivery: Buccal Route / 1071

Drug Delivery: Controlled Release / 1082

Drug Delivery: Fast-Dissolve Systems / 1104

Encyclopedia of

PHAR MACE UTICAL

TECH NOLOGY

Third Edition

VOLUME 1

Drugs and the Pharmaceutical Sciences

A comprehensive series of more than 160 volumes on all aspects of pharmaceutical science

Series Executive Editor: James Swarbrick

Herbal Supplements-Drug Interactions: Scientific

and Regulatory Perspectives

Edited by: Y.W. Francis Lam, Shiew-Mei Huang and

Stephen D. Hall

ISBN: 0-8247-2538-7

Introduction to the Pharmaceutical Regulatory

Process

Edited by: Ira R. Berry

ISBN: 0-8247-5464-6

Surfactants and Polymers in Drug Delivery

Martin Malmsten

ISBN: 0-8247-0804-0

Modern Pharmaceutics, Fourth Edition

Edited by: Gilbert S. Banker and

Christopher T. Rhodes

ISBN: 0-8247-0674-9

New Drug Development: Regulatory Paradigms for

Clinical Pharmacology and Biopharmaceutics

Edited by: Chandrah Sahajwalla

ISBN: 0-8247-5465-4

Dose Optimization In Drug Development

Edited by: Rajesh Krishna

ISBN: 1-5744-4808-0

Handbook of Pharmaceutical Analysis

Edited by: Lena Ohannesian

ISBN: 0-8247-0462-2

Spectroscopy of Pharmaceutical Solids

Edited by: Harry G. Brittain

ISBN: 1-5744-4893-5

Freeze-Drying/Lyophilization of Pharmaceutical

and Biological Products, Second Edition

Edited by: Louis Rey and Joan C. May

ISBN: 0-8247-4868-9

Drug-Drug Interactions

Edited by: A. David Rodrigues

ISBN: 0-8247-0283-2

Nanoparticle Technology for Drug Delivery

Edited by: Ram B. Gupta and Uday B. Kompella

ISBN: 1-5744-4857-9

Pharmaceutical Statistics, Fourth Edition

Sanford Bolton and Charles Bon

ISBN: 0-8247-4695-3

Handbook of Drug Screening

Edited by: Ramakrishn Seethala

ISBN: 0-8247-0562-9

Microencapsulation: Methods and Industrial

Applications, Second Edition

Edited by: Simon Benita

ISBN: 0-8247-2317-1

Pharmaceutical Inhalation Aerosol Technology,

Second Edition

Edited by: Anthony J. Hickey

ISBN: 0-8247-4253-2

Pharmaceutical Process Engineering

Edited by: Anthony J. Hickey

ISBN: 0-8247-0298-0

Pharmaceutical Process Scale-Up, Second Edition

Edited by: Michael Levin

ISBN: 1-5744-4876-5

Biomarkers in Clinical Drug Development

Edited by: John C. Bloom and Richard A. Dean

ISBN: 0-8247-4026-2

Drug Stability, Third Edition, Revised, and

Expanded: Principles and Practices

Edited by: Jens T. Carstensen

ISBN: 0-8247-0376-6

Pharmacogenomics, Second Edition

Edited by: Werner Kalow, Urs B. Meyer, and Rachel F.

Tyndale

ISBN: 1-5744-4878-1

Pharmaceutical Extrusion Technology

Edited by: Isa Ghebre-Selassie and Charles Martin

ISBN: 0-8247-4050-5

Coming Soon!

Handbook of Pharmaceutical Granulation

Technology, Second Edition

Edited by: Dilip M. Parikh

ISBN: 0-8247-2647-2

Pharmaceutical Gene Delivery Systems

Edited by: Alain Rolland and Sean M. Sullivan

ISBN: 0-8247-4235-4

November 2006

Environmental Monitoring for Cleanrooms and

Controlled Environments

Edited by: Anne Marie Dixon

ISBN: 0-8247-2359-7

Pharmaceutical Process Validation:

An International Third Edition

Edited by: Robert A. Nash and Alfred H. Wachter

ISBN: 0-8247-0838-5

Preclinical Drug Development

Edited by: Mark C. Rogge

ISBN: 1-5744-4882-X

Pharmaceutical Photostability and Stabilization

Technology

Edited by: Joseph T. Piechocki

ISBN: 0-8247-5924-9

Percutaneous Absorption: Drugs, Cosmetics,

Mechanisms, Methods, Fourth Edition

Edited by: Robert L. Bronaugh and Howard I. Maibach

ISBN: 1-5744-4869-2

Ophthalmic Drug Delivery Systems, Second

Edition

Edited by: Ashim K. Mitra

ISBN: 0-8247-4124-2

December 2006

Good Manufacturing Practices for

Pharmaceuticals: A Plan for Total Quality

Control from Manufacturer to Consumer, Sixth

Edited by: Joseph Nally

ISBN: 0-8493-3972-3

Pharmaceutical Stress Testing: Predicting Drug

Degradation

Edited by: Steven W. Baertschi

ISBN: 0-8247-4021-1

Affinity Capillary Electrophoresis in Pharmaceutics

and Biopharmaceutics

Edited by: Reinhard Neubert

ISBN: 0-8247-0951-9

February 2007

Pharmaceutical Product Development: In Vitro-In

Vivo Correlation

Edited by: Dakshina Chilukuri

ISBN: 0-8493-3827-1

Active Pharmaceutical Ingredients: Development,

Manufacturing, and Regulation

Edited by: Stanley Nusim

ISBN: 0-8247-0293-X

Parenteral Quality Control: Sterility, Pyrogen,

Particulate, and Package Integrity Testing:

Third Edition

Michael K. Akers, Daniel S. Larrimore, and Dana

Morton Guazzo

ISBN: 0-8247-0885-7

Injectable Dispersed Systems: Formulation,

Processing and Performance

Edited by: Diane J. Burgess

ISBN: 0-8493-3699-6

Endotoxins: Pyrogens, LAL Testing and

Depyrogenation, Third Edition

Kevin L. Williams

ISBN: 0-8493-9372-8

Modified-Release Drug Delivery Technology

Edited by: Michael J. Rathbone

ISBN: 0-8247-0869-5

April 2007

Good Laboratory Practice Regulations,

Fourth Edition

Edited by: Sandy Weinberg

ISBN: 0-8493-7583-5

Polymeric Drug Delivery Systems

Edited by: Glen S. Kwon

ISBN: 0-8247-2532-8

Simulation for Designing Clinical Trials: A

Pharmacokinetic-Pharmacodynamic Modeling

Perspective

Edited by: Hui Kimko

ISBN: 0-8247-0862-8

Drug Delivery to the Oral Cavity

Edited by: Tapash K. Ghosh and William Pfister

ISBN: 0-8247-8293-3

June 2007

Filtration and Purification in the Biopharmaceutical

Industry, Second Edition

Edited by: Theodore H. Meltzer and Maik Jornitz

ISBN: 0-8493-7953-9

Transdermal Drug Delivery

Second Edition

Edited by: Jonathan Hadgraft

ISBN: 0-8247-0861-X

Generic Drug Development: Solid Oral Dosage Forms

Edited by: Leon Shargel

ISBN: 0-8247-5460-3

To order, call 1-800-634-7064 (North America) or +44 (0) 1264 343071 (Intl.)

E-Mail books@informausa.com

Encyclopedia of

PHAR MACE UTICAL

TECH NOLOGY

Third Edition

VOLUME 1

edited by

James Swarbrick

PharmaceuTech, Inc.

Pinehurst, North Carolinia, USA

New York London

Swarbrick.J. - Encyclopedia of Pharmaceutical Technology v.1.pdf

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