Consider the Integration of Pharmacokinetic & Pharmacodynamic Concepts into the Biotech Drug Development Plan.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c43700) has announced the addition of Pharmacokinetics and Pharmacodynamics pharmacodynamics /phar·ma·co·dy·nam·ics/ (-di-nam´iks) the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical of Biotech Drugs: Principles and Case Studies in Drug Development to their offering. This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers. About the author Bernd Meibohm is an Associate Professor of Pharmaceutical Sciences at the College of Pharmacy A college of pharmacy generally refers to a tertiary educational institution (or part of such an institution) which is involved in the education of future pharmacists and pharmaconomists. of the University of Tennessee Health Science Center The University of Tennessee Health Science Center (UTHSC) in Memphis includes the Colleges of Allied Health Sciences, Dentistry, Graduate Health Sciences, Medicine, Nursing and Pharmacy. Its pediatric residency program is affiliated with Le Bonheur Children's Medical Center. , Memphis. He obtained his PhD from the University Carolo-Wilhelmina in Braunschweig, Germany, and underwent postdoctoral training in clinical pharmacology at the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. , Gainesville. His research is focused on pharmacokinetics (PK), pharmacodynamics (PD), and pharmacogenetics Pharmacogenetics Definition Pharmacogenetics is the study of how the actions of and reactions to drugs vary with the patient's genes. Description (PG) with special emphasis on PK/PD/PG correlations. Professor Meibohm is a Fellow of the American College of Clinical Pharmacology (ACCP ACCP American College of Chest Physicians ACCP American College of Clinical Pharmacy ACCP Army Correspondence Course Program ACCP Atlantic Climate Change Program ACCP Association of Caribbean Commissioners of Police ACCP Assembly of Caribbean Community Parliamentarians ) and has received numerous awards, including the `Young Investigator Award in PK, PD and Drug Metabolism? from the American Association of Pharmaceutical Scientists (AAPS AAPS American Association of Pharmaceutical Scientists AAPS Association of American Physicians and Surgeons AAPS Ann Arbor Public Schools AAPS American Association of Plastic Surgeons AAPS African Association of Political Science ) in 2000. He is currently serving as Section Editor for PK and PD for the `Journal of Clinical Pharmacology? and on the Editorial Boards of the `Journal of Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. Pharmacology and Therapeutics? and `Die Pharmazie?. Topics Covered The Role of Pharmacokinetics and Pharmacodynamics in the Development of Biotech Drugs Pharmacokinetics of Peptides and Proteins Pharmacokinetics of Monoclonal Antibodies Pharmacokinetics and Pharmacodynamics of Antisense Oligonucleotides Pharmacokinetics of Viral and Non-Viral Gene Delivery Vectors Bioanalytical Methods used for Pharmacokinetic Evaluations of Biotech Macromolecule macromolecule, term that may refer either to a crystal such as a diamond, in which the atoms are identical and held by covalent bonds (see chemical bond) of equal strength, or to one of the units that compose a polymer. Drugs: Issues, Assay Approaches, and Limitations Limitations of Noncompartmental Pharmacokinetic Analysis of Biotech Drugs Bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. of Biologics Biopharmaceutical Challenges in Pulmonary Delivery of Proteins and Peptides Biopharmaceutical Challenges: Delivery of Oligonucleotides Custom-Tailored Pharmacokinetics and Pharmacodynamics via Chemical Modifications of Biotech Drugs Exposure?Response Relationships for Therapeutic Biologic Products Preclinical and Clinical Drug Development of Tasidotin, a Depsi-Pentapeptide Oncolytic Agent Clinical Drug Development of Cetuximab, a Monoclonal Antibody Integration of Pharmacokinetics and Pharmacodynamics into the Drug Development of Pegfilgrastim, a Pegylated Protein Summary In recent years, biotechnologically-derived drugs (biotech drugs), including proteins, peptides, monoclonal antibodies and antibody fragments, as well as antisense oligonucleotides and DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. preparations for gene therapy, have been a major focus of R&D efforts in the pharmaceutical industry. According to the PHARMA 2010 report, biotech products accounted for more than 35% of the 37 new active substances that were launched in 2001. Furthermore, it has been predicted that half of all new active substances developed in the next 10 to 15 years will result from research into antibodies alone. Pharmacokinetics and pharmacokinetic/pharmacodynamic (PK/PD PK/PD Pharmacokinetic/Pharmacodynamic ) concepts impact every stage of the drug development process starting from lead optimization to the design of Phase III pivotal trials. An understanding of the concentration-effect relationship is crucial to any drug -- including biotech products -- since it lays the foundation for dosing regimen design and rational clinical application. General pharmacokinetic and pharmacodynamic principles are just as applicable to biotech agents as they are to traditional small molecule drugs. Pharmacokinetic and PK/PD analysis of biotech agents, however, frequently poses extra challenges and requires additional resources, since most biotech drugs are identical or similar to endogenous molecules. There is currently no comprehensive book on the market that addresses this issue, and thus the proposed book project will fill this void. Pharmacists, biotechnologists and pharmaceutical chemists working in drug development will need this book to understand the effects of biotech drugs in the human body. For more information visit http://www.researchandmarkets.com/reports/c43700 |
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