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"Discoveries in Pharmacology: Volume 1: Nervous system and hormones (2nd Ed.) presents selected articles from the historic Discoveries in Pharmacology series enhanced with commentary from contemporary scholars about the reception and importance of the chapter along with an updated bibliography on the subject with contributions from a Nobel Prize winner and other pioneers in Pharmacology. [ . . . ] This volume brings forth discussions on key discoveries in psycho- and neuro-pharmacology, haemodynamics, and hormones including chapters on antipsychotic agents by Nobel winner Anders Carlsson, Willy Haefely on benzodiazepine, and butyrophenone-type neuroleptics by P. A. J. Janssen and J. P. Tollenaere."--

Drug Development. --- Pharmacological and Toxicological Phenomena. --- Nervous System --- Hormones. --- drug effects. --- Hormone --- Hormone Receptor Agonists --- Agonists, Hormone Receptor --- Receptor Agonists, Hormone --- Endocrine Glands --- Pharmacologic and Toxicologic Phenomena --- Pharmacological and Toxicological Concepts --- Pharmacological and Toxicological Processes --- Pharmacotoxicologic Phenomena --- Pharmacotoxicologic Phenomenon --- Pharmacotoxicological Phenomena --- Pharmacotoxicological Phenomenon --- Toxicopharmacological Phenomena --- Toxicopharmacological Phenomenon --- Phenomena, Pharmacotoxicologic --- Phenomena, Pharmacotoxicological --- Phenomena, Toxicopharmacological --- Phenomenon, Pharmacotoxicologic --- Phenomenon, Pharmacotoxicological --- Phenomenon, Toxicopharmacological --- Pharmacologic Actions --- Medication Development --- Pharmaceutical Development --- Computational Prediction of Drug-Target Interactions --- Drug Target Prediction --- Development, Drug --- Development, Medication --- Development, Pharmaceutical --- Drug Target Predictions --- Prediction, Drug Target --- Target Prediction, Drug --- Nervous system. --- Neuropharmacology.. --- Pharmacology. --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Drugs --- Pharmacy --- Nervous system --- Neurotropic drugs --- Neurosciences --- Pharmacology --- Organs (Anatomy) --- Physiological effect --- Effect of drugs on --- Neuropharmacology --- History. --- history --- history.

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This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value. .

Oncology  . --- Radiotherapy. --- Oncology. --- Radiation therapy --- Electrotherapeutics --- Hospitals --- Medical electronics --- Medical radiology --- Therapeutics, Physiological --- Phototherapy --- Tumors --- Radiological services --- Antineoplastic agents --- Cancer --- Drug development. --- Design. --- Chemotherapy. --- Development of drugs --- Drugs --- New drug development --- Pharmacology --- Pharmacy --- Anticancer agents --- Antineoplastic drugs --- Antineoplastics --- Antitumor agents --- Antitumor drugs --- Cytotoxic drugs --- Inhibitors, Neoplasm --- Neoplasm inhibitors --- Development --- Treatment --- Chemotherapy --- Antineoplastic Agents. --- Drug Development. --- Neoplasms --- Clinical Trials, Phase I as Topic. --- drug therapy. --- Clinical Trials, Phase 1 --- Drug Evaluation, FDA Phase 1 --- Drug Evaluation, FDA Phase I as Topic --- Evaluation Studies, FDA Phase 1 --- Human Microdosing Trials --- Microdosing Trials, Human --- Phase 1 Clinical Trials --- Clinical Trials, Phase I --- Drug Evaluation, FDA Phase I --- Evaluation Studies, FDA Phase I --- Human Microdosing Trial --- Phase 1 Clinical Trial --- Phase I Clinical Trial --- Phase I Clinical Trials --- Microdosing Trial, Human --- Trial, Human Microdosing --- Trials, Human Microdosing --- Nontherapeutic Human Experimentation --- Medication Development --- Pharmaceutical Development --- Computational Prediction of Drug-Target Interactions --- Drug Target Prediction --- Development, Drug --- Development, Medication --- Development, Pharmaceutical --- Drug Target Predictions --- Prediction, Drug Target --- Target Prediction, Drug --- Anticancer Agents --- Antineoplastic Drugs --- Antitumor Agents --- Antitumor Drugs --- Cancer Chemotherapy Agents --- Cancer Chemotherapy Drugs --- Chemotherapeutic Anticancer Agents --- Chemotherapeutic Anticancer Drug --- Anticancer Agent --- Antineoplastic --- Antineoplastic Agent --- Antineoplastic Drug --- Antitumor Agent --- Antitumor Drug --- Cancer Chemotherapy Agent --- Cancer Chemotherapy Drug --- Agent, Anticancer --- Agent, Antineoplastic --- Agent, Antitumor --- Agent, Cancer Chemotherapy --- Agents, Anticancer --- Agents, Antineoplastic --- Agents, Antitumor --- Agents, Cancer Chemotherapy --- Agents, Chemotherapeutic Anticancer --- Chemotherapy Agent, Cancer --- Chemotherapy Agents, Cancer --- Chemotherapy Drug, Cancer --- Chemotherapy Drugs, Cancer --- Drug, Antineoplastic --- Drug, Antitumor --- Drug, Cancer Chemotherapy --- Drug, Chemotherapeutic Anticancer --- Drugs, Antineoplastic --- Drugs, Antitumor --- Drugs, Cancer Chemotherapy --- Cytotoxins --- Interferon Inducers --- Anticarcinogenic Agents

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Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Drug Development. --- Drug Design. --- Nanoparticle Drug Delivery System. --- Risk Evaluation and Mitigation --- ETASU --- Elements to Assure Safe Use --- Computer-Aided Drug Design --- Computerized Drug Design --- Drug Modeling --- Pharmaceutical Design --- Computer Aided Drug Design --- Computer-Aided Drug Designs --- Computerized Drug Designs --- Design, Pharmaceutical --- Drug Design, Computer-Aided --- Drug Design, Computerized --- Drug Designs --- Drug Modelings --- Pharmaceutical Designs --- NDDSs --- Nano Delivery System --- Nano Drug Delivery Systems --- Nano-Drug Delivery System --- Nanoparticle Based Drug Delivery System --- Delivery System, Nano --- Delivery System, Nano-Drug --- Delivery Systems, Nano --- Delivery Systems, Nano-Drug --- Nano Delivery Systems --- Nano Drug Delivery System --- System, Nano Delivery --- System, Nano-Drug Delivery --- Systems, Nano Delivery --- Systems, Nano-Drug Delivery --- Medication Development --- Pharmaceutical Development --- Computational Prediction of Drug-Target Interactions --- Drug Target Prediction --- Development, Drug --- Development, Medication --- Development, Pharmaceutical --- Drug Target Predictions --- Prediction, Drug Target --- Target Prediction, Drug --- Drug development. --- Drugs --- Pharmaceutical industry --- Design. --- Quality control. --- Drug design --- Pharmaceutical design --- Drug development --- Development of drugs --- New drug development --- Pharmacology --- Pharmacy --- Development --- Pharmacology. --- Pharmaceutical chemistry. --- Pharmaceutics. --- Chemistry, Medical and pharmaceutical --- Chemistry, Pharmaceutical --- Drug chemistry --- Medical chemistry --- Medicinal chemistry --- Pharmacochemistry --- Chemistry --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Physiological effect