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Pharmaceutical industry --- Drug development. --- Quality control. --- Drug Development. --- Efficiency, Organizational. --- Total Quality Management. --- Development of drugs --- Drugs --- New drug development --- Pharmacology --- Pharmacy --- Development --- Lean Six Sigma --- Sigma Metrics --- Six Sigma --- Continuous Quality Management --- Lean Six Sigmas --- Management, Continuous Quality --- Management, Total Quality --- Metric, Sigma --- Metrics, Sigma --- Sigma Metric --- Sigma, Six --- Sigmas, Six --- Six Sigma, Lean --- Six Sigmas --- Six Sigmas, Lean --- Quality Control --- Administrative Efficiency --- Organizational Productivity --- Efficiency, Administrative --- Productivity, Organizational --- Program Efficiency --- Efficiency, Program --- Organizational Efficiency --- Program Efficiencies --- 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

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"The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management"--

Ethics and addiction --- Pharmaceutical industry --- Drug development. --- Drug Development. --- Efficiency, Organizational. --- Total Quality Management. --- Quality control. --- Lean Six Sigma --- Sigma Metrics --- Six Sigma --- Continuous Quality Management --- Lean Six Sigmas --- Management, Continuous Quality --- Management, Total Quality --- Metric, Sigma --- Metrics, Sigma --- Sigma Metric --- Sigma, Six --- Sigmas, Six --- Six Sigma, Lean --- Six Sigmas --- Six Sigmas, Lean --- Quality Control --- Administrative Efficiency --- Organizational Productivity --- Efficiency, Administrative --- Productivity, Organizational --- Program Efficiency --- Efficiency, Program --- Organizational Efficiency --- Program Efficiencies --- 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 --- Development of drugs --- Drugs --- New drug development --- Pharmacology --- Pharmacy --- Development

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drug discovery --- drug delivery --- medicinal chemistry --- drug development and commercialization --- translational science --- cell therapy --- Pharmacy --- Drug development --- Drugs --- Drug development. --- Drug Discovery. --- Drug Development. --- Research --- Design --- Testing --- Design. --- Testing. --- Research. --- 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 Prospecting --- Discovery, Drug --- Prospecting, Drug --- High-Throughput Screening Assays --- Bioprospecting --- Clinical drug trials --- Clinical trials of drugs --- Drug bioscreening --- Drug trials --- Clinical pharmacology --- Drug design --- Pharmaceutical design --- Development of drugs --- New drug development --- Pharmacology --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Chemistry --- Medicine --- Clinical trials --- Effectiveness --- Evaluation --- Development --- Drug Discovery --- Drug Development

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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

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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