{"product_id":"chemical-engineering-in-the-pharmaceutical-industry-isbn-9781119285496","title":"Chemical Engineering in the Pharmaceutical Industry","description":"\u003cp\u003e\u003cb\u003eA guide to the important chemical engineering concepts for the development of new drugs, revised second edition\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe revised and updated second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003e offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling.\u003c\/p\u003e \u003cp\u003eThe contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eContains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions\u003c\/li\u003e \u003cli\u003eCovers chemistry and engineering activities related to dosage form design, and process development, and scale-up\u003c\/li\u003e \u003cli\u003eOffers analytical methods and applied statistics that highlight drug product quality attributes as design features\u003c\/li\u003e \u003cli\u003ePresents updated and new example calculations and associated solutions\u003c\/li\u003e \u003cli\u003eIncludes contributions from leading experts in the field\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing,\u003ci\u003e Chemical Engineering in the Pharmaceutical Industry, Second Edition\u003c\/i\u003e contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.\u003c\/p\u003e \u003cp\u003eList of Contributors ix\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eUnit Conversions xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Introduction 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3\u003cbr\u003e\u003ci\u003eDavid J. am Ende \u003c\/i\u003eand\u003ci\u003e Mary T. am Ende\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Drug Product Design, Development, and Modeling 19\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2 Design of Solid Dosage Formulations 21\u003cbr\u003e\u003ci\u003eKevin J. Bittorf, Tapan Sanghvi, \u003c\/i\u003eand\u003ci\u003e Jeffrey P. Katstra\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Powder Process Challenges and Solutions 53\u003cbr\u003e\u003ci\u003eThomas Baxter \u003c\/i\u003eand\u003ci\u003e James Prescott\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Design and Scale-up of Dry Granulation Processes 81\u003cbr\u003e\u003ci\u003eHoward J. Stamato \u003c\/i\u003eand\u003ci\u003e Omar L. Sprockel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Model-based Development of Roller Compaction Processes 119\u003cbr\u003e\u003ci\u003eGavin Reynolds\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Wet Granulation Processes 147\u003cbr\u003e\u003ci\u003eKaren P. Hapgood \u003c\/i\u003eand\u003ci\u003e James D. Litster\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Toward a Generic Model for Twin-screw Wet Granulation 173\u003cbr\u003e\u003ci\u003eDaan Van Hauwermeiren, Maxim Verstraeten, Michaël Ghijs, Kai Lee, Neil Turnbull, Mary T. am Ende, Pankaj Doshi, David Wilsdon, Thomas De Beer, \u003c\/i\u003eand\u003ci\u003e Ingmar Nopens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Modeling a Dosator Capsule Filling Process for Hard-shell Capsules 187\u003cbr\u003e\u003ci\u003ePeter Loidolt, Eva Faulhammer, \u003c\/i\u003eand\u003ci\u003e Johannes G. Khinast\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Powder Compaction: Process Design and Understanding 203\u003cbr\u003e\u003ci\u003eDavid Wilson, Ron Roberts, \u003c\/i\u003eand\u003ci\u003e John Blyth\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Punch Sticking: Factors and Solutions 227\u003cbr\u003e\u003ci\u003eDaryl M. Simmons\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Spray Atomization Modeling for Tablet Film Coating Processes 245\u003cbr\u003e\u003ci\u003eAlfred Berchielli, Pankaj Doshi, Alberto Aliseda, \u003c\/i\u003eand\u003ci\u003e Juan C. Lasheras\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Spray Drying and Amorphous Dispersions 267\u003cbr\u003e\u003ci\u003eKristin J.M. Ploeger, Pavithra Sundararajan, Pedro C. Valente, Kenneth J. Rosenberg, João G. Henriques, \u003c\/i\u003eand\u003ci\u003e Paige Adack\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 The Freeze Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale-up 293\u003cbr\u003e\u003ci\u003eVenkat Koganti, Sumit Luthra, \u003c\/i\u003eand\u003ci\u003e Michael J. Pikal\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Sterilization Processes in the Pharmaceutical Industry 311\u003cbr\u003e\u003ci\u003ePiero M. Armenante \u003c\/i\u003eand\u003ci\u003e Otute Akiti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms 381\u003cbr\u003e\u003ci\u003eAvinash G. Thombre, Xiao Yu (Shirley) Wu, \u003c\/i\u003eand\u003ci\u003e Mary T. am Ende\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Process Design and Development for Novel Pharmaceutical Dosage Forms 409\u003cbr\u003e\u003ci\u003eLeah Appel, Joshua Shockey, Matthew Shaffer, \u003c\/i\u003eand\u003ci\u003e Jennifer Chu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 Multiscale Modeling of a Pharmaceutical Fluid Bed Coating Process Using CFD\/DEM and Population Balance Models to Predict Coating Uniformity 419\u003cbr\u003e\u003ci\u003eAvik Sarkar, Dalibor Jajcevic, Peter Böhling, Peter Toson, Matej Zadravec, Brian Shoemaker, Pankaj Doshi, Johannes Khinast, \u003c\/i\u003eand\u003ci\u003e Mary T. am Ende\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 Process Design of Topical Semisolids: Application of Fundamental Concepts in Pharmaceutical Engineering to PEG Ointment Development 451\u003cbr\u003e\u003ci\u003eAmanda Samuel, Thean Yeoh, Rolf Larsen, \u003c\/i\u003eand\u003ci\u003e Avik Sarkar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions 469\u003cbr\u003e\u003ci\u003eLuke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, \u003c\/i\u003eand\u003ci\u003e Craig Mckelvey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Drug Product Process Modeling 489\u003cbr\u003e\u003ci\u003eMary T. am Ende, William Ketterhagen, Andrew Prpich, Pankaj Doshi, Salvador García-Muñoz, \u003c\/i\u003eand\u003ci\u003e Rahul Bharadwajh\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Continuous Manufacturing 527\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21 Continuous Manufacturing in Secondary Production 529\u003cbr\u003e\u003ci\u003eMartin Warman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Continuous Direct Compression Using Portable Continuous Miniature Modular \u0026amp; Manufacturing (PCM\u0026amp;M) 547\u003cbr\u003e\u003ci\u003eDaniel O. Blackwood, Alexandre Bonnassieux, \u003c\/i\u003eand\u003ci\u003e Giuseppe Cogoni\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Process Control Levels for Continuous Pharmaceutical Tablet Manufacturing 561\u003cbr\u003e\u003ci\u003eNiels Nicolaï, Ingmar Nopens, Maxim Verstraeten, \u003c\/i\u003eand\u003ci\u003e Thomas De Beer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Applied Statistics and Regulatory Environment 585\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24 Multivariate Analysis for Pharmaceutical and Medical Device Development 587\u003cbr\u003e\u003ci\u003eFrederick H. Long\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization 601\u003cbr\u003e\u003ci\u003eTheodora Kourti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Quality by Design: Pilot to Reality-The Honeymoon Phase to the Stormy Years 631\u003cbr\u003e\u003ci\u003eMary T. am Ende \u003c\/i\u003eand\u003ci\u003e Christine B. Seymour\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 645\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eMary T. am Ende, P\u003csmall\u003eH\u003c\/small\u003eD,\u003c\/b\u003e is Vice President of Process Development at Lyndra Therapeutics, Inc. Previously, she was a Research Fellow at Pfizer, Inc. in Drug Product Design. She has over 25 years' experience in drug product formulation, process development and computational modeling.  \u003c\/p\u003e\u003cp\u003e\u003cb\u003eDavid J. am Ende, P\u003csmall\u003eH\u003c\/small\u003eD,\u003c\/b\u003e is President of Nalas Engineering Services, Inc. Previously, he was Research Fellow at Pfizer Inc. in the Chemical Research \u0026amp; Development department. He has over 25 years experience in chemical process development.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA GUIDE TO THE IMPORTANT CHEMICAL ENGINEERING SECOND EDITION CONCEPTS FOR THE DEVELOPMENT OF NEW DRUGS, REVISED SECOND EDITION\u003c\/b\u003e  \u003c\/p\u003e\u003cp\u003eThe revised and updated second edition of \u003ci\u003eChemical Engineering in the Pharmaceutical Industry\u003c\/i\u003e offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API's) and 2) Drug Product Design, Development and Modeling.  \u003c\/p\u003e\u003cp\u003eThe contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eContains 26 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions\u003c\/li\u003e \u003cli\u003eCovers chemistry and engineering activities related to dosage form design, process development, and scale-up\u003c\/li\u003e \u003cli\u003eOffers analytical methods and applied statistics that highlight drug product quality attributes as design features\u003c\/li\u003e \u003cli\u003ePresents updated and new example calculations and associated solutions\u003c\/li\u003e \u003cli\u003eIncludes contributions from leading experts in the field\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, \u003ci\u003eChemical Engineering in the Pharmaceutical Industry, Second Edition\u003c\/i\u003e contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988905738469,"sku":"NP9781119285496","price":262.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119285496.jpg?v=1761781998","url":"https:\/\/k12savings.com\/es\/products\/chemical-engineering-in-the-pharmaceutical-industry-isbn-9781119285496","provider":"K12savings","version":"1.0","type":"link"}