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ویرایش: سری: ISBN (شابک) : 9780470248478, 9780470249031 ناشر: سال نشر: 2008 تعداد صفحات: 1325 زبان: English فرمت فایل : PDF (درصورت درخواست کاربر به PDF، EPUB یا AZW3 تبدیل می شود) حجم فایل: 25 مگابایت
در صورت تبدیل فایل کتاب Preclinical Development Handbook: ADME and Biopharmaceutical Properties به فرمت های PDF، EPUB، AZW3، MOBI و یا DJVU می توانید به پشتیبان اطلاع دهید تا فایل مورد نظر را تبدیل نمایند.
توجه داشته باشید کتاب کتابچه راهنمای توسعه بالینی: ADME و خصوصیات زیست داروئی نسخه زبان اصلی می باشد و کتاب ترجمه شده به فارسی نمی باشد. وبسایت اینترنشنال لایبرری ارائه دهنده کتاب های زبان اصلی می باشد و هیچ گونه کتاب ترجمه شده یا نوشته شده به فارسی را ارائه نمی دهد.
A clear, straightforward resource to guide you through
preclinical drug development
Following this book's step-by-step guidance, you can
successfully initiate and complete critical phases of
preclinical drug development. The book serves as a basic,
comprehensive reference to prioritizing and optimizing leads,
dose formulation, ADME, pharmacokinetics, modeling, and
regulations. This authoritative, easy-to-use resource covers
all the issues that need to be considered and provides detailed
instructions for current methods and techniques.
Each chapter is written by one or more leading experts in the
field. These authors, representing the many disciplines
involved in preclinical toxicology screening and testing, give
you the tools needed to apply an effective multidisciplinary
approach. The editor has carefully reviewed all the chapters to
ensure that each one is thorough, accurate, and clear.
Among the key topics covered are:
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Modeling and informatics in drug design
*
Bioanalytical chemistry
*
Absorption of drugs after oral administration
*
Transporter interactions in the ADME pathway of drugs
*
Metabolism kinetics
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Mechanisms and consequences of drug-drug interactions
Each chapter offers a full exploration of problems that may be
encountered and their solutions. The authors also set forth the
limitations of various methods and techniques used in
determining the safety and efficacy of a drug during the
preclinical stage.
This publication should be readily accessible to all
pharmaceutical scientists involved in preclinical testing,
enabling them to perform and document preclinical safety tests
to meet all FDA requirements before clinical trials may
begin.Content:
Chapter 1 Modeling and Informatics in Drug Design (pages 1–45):
Prasad V. Bharatam, Smriti Khanna and Sandrea M. Francis
Chapter 2 Computer Techniques: Identifying Similarities between
Small Molecules (pages 47–86): Peter Meek, Guillermo Moyna and
Randy Zauhar
Chapter 3 Protein–Protein Interactions (pages 87–116): Kamaljit
Kaur, Dipankar Das and Mavanur R. Suresh
Chapter 4 Method Development for Preclinical Bioanalytical
Support (pages 117–150): Masood Khan and Naidong Weng
Chapter 5 Analytical Chemistry Methods: Developments and
Validation (pages 151–210): Izet M. Kapetanovic and Alexander
V. Lyubimov
Chapter 6 Chemical and Physical Characterizations of Potential
New Chemical Entity (pages 211–225): Adegoke Adeniji and
Adeboye Adejare
Chapter 7 Permeability Assessment (pages 227–248): Srinivas
Ganta, Puneet Sharma and Sanjay Garg
Chapter 8 How and Where Are Drugs Absorbed? (pages 249–280):
Marival Bermejo and Isabel Gonzalez?Alvarez
Chapter 9 Absorption of Drugs after Oral Administration (pages
281–321): Luis Granero and Ana Polache
Chapter 10 Distribution: Movement of Drugs through the Body
(pages 323–352): Jayanth Panyam and Yogesh Patil
Chapter 11 The Blood–Brain Barrier and its Effect on Absorption
and Distribution (pages 353–406): A. G. de Boer and P. J.
Gaillard
Chapter 12 Transporter Interactions in the ADME Pathway of
Drugs (pages 407–427): Yan Zhang and Donald W. Miller
Chapter 13 Accumulation of Drugs in Tissues (pages 429–453):
Krishnamurthy Venkatesan, Deepa Bisht and Mohammad Owais
Chapter 14 Salt and Cocrystal Form Selection (pages 455–481):
Ann W. Newman, Scott L. Childs and Brett A. Cowans
Chapter 15 Dissolution (pages 483–544): A. K. Tiwary, Bharti
Sapra and Subheet Jain
Chapter 16 Stability: Physical and Chemical (pages 545–570):
Eric M. Gorman, Brian E. Padden and Eric J. Munson
Chapter 17 Dosage Formulation (pages 571–626): Alexander V.
Lyubimov
Chapter 18 Cytochrome P450 Enzymes (pages 627–696): Eugene G.
Hrycay and Stelvio M. Bandiera
Chapter 19 Metabolism Kinetics (pages 697–713): Charles W.
Locuson and Timothy S. Tracy
Chapter 20 Drug Clearance (pages 715–742): Sree D. Panuganti
and Craig K. Svensson
Chapter 21 In Vitro Metabolism in Preclinical Drug Development
(pages 743–774): Olavi Pelkonen, Ari Tolonen, Miia Turpeinen
and Jouko Uusitalo
Chapter 22 Utilization of In Vitro Cytochrome P450 Inhibition
Data for Projecting Clinical Drug–Drug Interactions (pages
775–827): Jane R. Kenny, Dermot F. McGinnity, Ken Grime and
Robert J. Riley
Chapter 23 In Vivo Metabolism in Preclinical Drug Development
(pages 829–851): Sevim Rollas
Chapter 24 In Vitro Evaluation of Metabolic Drug–Drug
Interactions: Scientific Concepts and Practical Considerations
(pages 853–877): Albert P. Li
Chapter 25 Mechanisms and Consequences of Drug–Drug
Interactions (pages 879–917): Dora Farkas, Richard I. Shader,
Lisa L. von Moltke and David J. Greenblatt
Chapter 26 Species Comparison of Metabolism in Microsomes and
Hepatocytes (pages 919–935): Niels Krebsfaenger
Chapter 27 Metabolite Profiling and Structural Identification
(pages 937–974): Mehran F. Moghaddam
Chapter 28 Linkage between Toxicology of Drugs and Metabolism
(pages 975–1008): Ruiwen Zhang and Elizabeth R. Rayburn
Chapter 29 Allometric Scaling (pages 1009–1035): William L.
Hayton and Teh?Min Hu
Chapter 30 Interrelationship between Pharmacokinetics and
Metabolism (pages 1037–1058): James W. Paxton
Chapter 31 Experimental Design Considerations in
Pharmacokinetic Studies (pages 1059–1068): William W. Hope,
Vidmantas Petraitis and Thomas J. Walsh
Chapter 32 Bioavailability and Bioequivalence Studies (pages
1069–1101): Alexander V. Lyubimov and Ihor Bekersky
Chapter 33 Mass Balance Studies (pages 1103–1131): Jan H.
Beumer, Julie L. Eiseman and Merrill J. Egorin
Chapter 34 Pharmacodynamics (pages 1133–1166): Beom Soo Shin,
Dhaval Shah and Joseph P. Balthasar
Chapter 35 Physiologically Based Pharmacokinetic Modeling
(pages 1167–1227): Harvey J. Clewell, Micaela B. Reddy, Thierry
Lave and Melvin E. Andersen
Chapter 36 Mathematical Modeling as a New Approach for
Improving the Efficacy/Toxicity Profile of Drugs: The
Thrombocytopenia Case Study (pages 1229–1266): Zvia Agur, Moran
Elishmereni, Yuri Kogan, Yuri Kheifetz, Irit Ziv, Meir Shoham
and Vladimir Vainstein
Chapter 37 Regulatory Requirements for INDs/FIH (First in
Human) Studies (pages 1267–1307): Shayne Cox Gad
Chapter 38 Data Analysis (pages 1309–1322): Jayesh Vora and
Pankaj B. Desai