Preclinical Development Handbook: ADME and Biopharmaceutical PropertiesShayne Cox Gad John Wiley & Sons, 14 de mar. de 2008 - 1352 páginas 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: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * 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. |
Conteúdo
Contents | 3 |
Modeling and Informatics in Drug Design 1 | 16 |
2 | 48 |
4 | 118 |
Developments and Validation | 151 |
Chemical and Physical Characterizations of Potential | 211 |
Permeability Assessment | 227 |
How and Where Are Drugs Absorbed? | 249 |
Utilization of In Vitro Cytochrome P450 Inhibition Data | 775 |
In Vivo Metabolism in Preclinical Drug Development | 829 |
Scientific | 853 |
von Moltke Tufts University School of Medicine Boston Massachusetts | 879 |
Jayesh Vora PRTM Management Consultants Mountain View California Data | 902 |
Species Comparison of Metabolism in Microsomes and Hepatocytes | 919 |
Metabolite Profiling and Structural Identification | 937 |
Ruiwen Zhang University of Alabama at Birmingham Birmingham Alabama | 975 |
Absorption of Drugs after Oral Administration | 281 |
Movement of Drugs through the Body | 323 |
The BloodBrain Barrier and Its Effect on Absorption | 353 |
Transporter Interactions in the ADME Pathway of Drugs | 407 |
Accumulation of Drugs in Tissues | 429 |
Salt and Cocrystal Form Selection | 455 |
Dissolution | 483 |
Physical and Chemical | 545 |
Dosage Formulation | 571 |
Cytochrome P450 Enzymes | 627 |
Metabolism Kinetics | 697 |
Drug Clearance | 715 |
In Vitro Metabolism in Preclinical Drug Development | 743 |
Allometric Scaling | 1009 |
Interrelationship between Pharmacokinetics and Metabolism | 1037 |
Experimental Design Considerations in Pharmacokinetic Studies | 1059 |
32 | 1070 |
Mass Balance Studies | 1103 |
Pharmacodynamics | 1133 |
Physiologically Based Pharmacokinetic Modeling | 1167 |
Irit Ziv Optimata Ltd RamatGan Israel Mathematical Modeling as a | 1229 |
37 | 1268 |
Data Analysis | 1309 |
1323 | |
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Preclinical Development Handbook: ADME and Biopharmaceutical Properties Shayne Cox Gad Visualização parcial - 2008 |
Preclinical Development Handbook: ADME and Biopharmaceutical Properties Shayne Cox Gad Prévia não disponível - 2008 |
Termos e frases comuns
absorption acid activity addition administration analysis analytical application approach assay barrier binding blood brain cells changes Chem chemical chromatography clearance Clin clinical compared complex components compounds concentration containing cytochrome P450 delivery determined dissolution distribution dosage drug Drug Metab effect enhanced enzymes evaluation example expression factors formulation function gene groups hepatic hepatocytes human identified important increase induced inhibition inhibitor interactions intestinal involved kinetics limited liver mass measured mechanism membrane metabolism metabolites method microsomes molecular molecules oral organic P-glycoprotein peptide permeability Pharm pharmaceutical pharmacokinetic Pharmacol phase plasma possible potential prediction preparation present properties protein reaction receptor release sample screening selection silico solubility specific stability structure studies substrate surface Table tablets techniques tion tissue transport validation values various vitro vivo