1st Edition

Nonclinical Drug Administration Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

By Shayne C. Gad, Charles B. Spainhour Copyright 2018
    420 Pages 11 B/W Illustrations
    by CRC Press

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    If we will ever achieve Paul Ehrlich’s "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology.

    The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity.

    The book’s ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.

    Pharmacotherapy, Toxicodynamics and Regulatory Science—Divergent Objectives

    Nonclinical Pharmacokinetics - a primer

    Routes - with considerations for species specificity

    Delivery Systems


    Fundamentals of Nonclinical Formulation

    Excipients and Vehicles: Tolerance and toxicity



    Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1971) and after active duty service in U.S. Navy, Ph.D. in Pharmacology/Toxicology (Texas, 1977)  DABT,  Principal  of  Gad  Consulting  Services,  a  twenty-four  year  old  consulting >rm with nine employees and more than 500 clients worldwide in  the  pharmaceutical  and  medical  device  industries.  Past  President  of  the  American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award in 2008. Served on Council, Membership, Program, and Animals in Research committees for ACT, mul-tiple committees in SOT, and currently on the regulatory opinions commit-tee of the Society of Toxicologic Pathologists. Previously at CMIR Chemical Hygiene   Fellowship,   Allied   Chemical,   Searle,   Becton   Dickinson   and   Synergen. He has authored or edited 49 published books and more than 350 chapters, articles and abstracts in the >elds of toxicology, statistics, pharma-cology,  drug  and  device  development  and  safety  assessment.  He  has  more  than 39 years of broad based experience in regulatory toxicology, drug and device  development,  statistics  and  risk  assessment,  and  has  speci>c  exper-tise  in  neurotoxicology,  in  vitro  methods,  cardiovascular  toxicology,  inha-lation  toxicology,  immunotoxicology,  risk  assessment  and  genotoxicology.  Grant  reviewer  for  EPA,  CAAT,  NIH,  and  Canadian  Health.  He  has  direct  involvement  in  the  preparation  of  INDs  (111 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and  PMAs. Served as the COO of two pharmaceutical companies while a consultant.

    Charles  B. Spainhour has amassed approximately forty-seven years of experience  in  the  pharmaceutical  industry.  For  his  >rst  >fteen  years  Dr. Spainhour worked at a company known then as Smith Kline & French Laboratories and now as GlaxoSmithKline Corp., where he held positions in both the research and the development segments of the drug development process. Speci>cally, on the research side Dr. Spainhour’s activities involved the  areas  of  phosphodiesterase  inhibition,  anti-diuretic  hormone  agonism  and  antagonism,  dopamine  agonism  and  antagonism,  neuroleptic  bio-chemistry,  anti-  infective  mechanisms  and  structure-activity-  relationships.  On  the  development,  side  Dr.  Spainhour  worked  in  pharmacokinetics  &  metabolism,  radiosynthesis,  process  chemistry  and  drug  safety  evalua-tion. Speci>c areas of endeavor  included  H2-antagonists,  leukotrienes,  anti-   infectives,   anti-hypertensives,   anti-   hyperglycemic   agents   and   anti-arrhythmics.  Dr.  Spainhour  played  a  key  role  in  the  development  of  the  >rst  H2-antagonist,  Cimetidine®  and  worked  closely  with  Sir  James  Black. Dr.  Spainhour  has  a  great  interest  and  copious  amount  of  experience  in  the  research  and  development  of  natural  products.  Dr.  Spainhour    has  also  worked as an independent consultant in the areas of safety assessment and forensic toxicology, held a position on the faculty at the veterinary school of Texas  A&M  University  and  worked  as  a  Toxicologist  in  the  CRO  Industry  previously  for  Pharmakon  Research  International,  Chrysalis  International,  Phoenix  International  Life  Sciences  and  MDS  Pharma  Services.  Currently  Dr.  Spainhour  serves  as  the  Executive  Vice-President  and  Chief  Scienti>c  Of>cer  for  Calvert  Laboratories  and  Calvert  Holdings  and  is  the  President  and Chief Scienti>c Of>cer of Spainhour & Associates LLC. Dr. Spainhour holds  a  B.S.  from  Michigan  State  University  in  Biochemistry,  a  veterinary  degree  from  the  University  of  Pennsylvania  and  a  Ph.D.  from  Texas  A&M  University  (Developmental  Toxicology),  and  is  board  certi>ed  in  forensic  science, toxicology and forensic medicine.