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Book
Principles of parenteral solution validation : a practical lifecycle approach
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ISBN: 012809446X 0128094125 9780128094129 9780128094464 Year: 2020 Publisher: London : Academic Press,


Book
How to integrate quality by efficient design (QbED) in product development
Author:
ISBN: 0128173041 0128168137 9780128168134 9780128173046 Year: 2020 Publisher: London, United Kingdom


Book
How to integrate quality by efficient design (QbED) in product development
Author:
ISBN: 9780128173046 0128173041 9780128168134 Year: 2020 Publisher: London, United Kingdom : Academic Press an imprint of Elsevier,

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Abstract

"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"--


Book
Pharmaceutical biotechnology in drug development
Authors: --- --- ---
ISBN: 0443191352 0443191360 9780443191367 9780443191350 Year: 2023 Publisher: San Diego, CA : Academic press, and imprint of Elsevier,

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Pharmaceutical Biotechnology in Drug Development summarizes key concepts and the latest developments of biotechnology applied to the development of biopharmaceuticals. Chapters present a comprehensive collection of introductory biotechnology technologies and their modern concepts and cover pharmacokinetic and pharmacodynamic behavior of biopharmaceuticals and modification techniques of amino acids and nucleic acid. Other sections focus on topics such as gene therapy, immunological preparations and nanoparticles which are the major contributions of pharmaceutical biotechnology. Final chapters discuss emerging techniques in the field of pharmaceutical biotechnology to meet current patient and health care demand. This book is an essential reference useful for pharmaceutical scientists, clinicians and academic researchers who want easy access to up-to-date practices of pharmaceutical biotechnology. Corporate researchers will also benefit from this book’s succinct and objective content structure.


Periodical
Medicine in drug discovery.
Authors: ---
ISSN: 25900986 Year: 2019 Publisher: [Amsterdam] : Elsevier B.V.,


Book
Translational medicine in CNS drug development
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ISBN: 0128031646 0128031611 9780128031643 9780128031612 Year: 2019 Publisher: London, England : Academic Press,

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Book
Discoveries in pharmacology.
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ISBN: 0323855202 9780323855198 0323855199 9780323855204 Year: 2023 Publisher: London, England : Academic Press,

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Book
Drug-Drug Interactions
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Year: 2021 Publisher: Basel, Switzerland MDPI - Multidisciplinary Digital Publishing Institute

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Abstract

Drug–drug interactions (DDIs) cause a drug to affect other drugs, leading to reduced drug efficacy or increased toxicity of the affected drug. Some well-known interactions are known to be the cause of adverse drug reactions (ADRs) that are life threatening to the patient. Traditionally, DDI have been evaluated around the selective action of drugs on specific CYP enzymes. The interaction of drugs with CYP remains very important in drug interactions but, recently, other important mechanisms have also been studied as contributing to drug interaction including transport- or UDP-glucuronyltransferase as a Phase II reaction-mediated DDI. In addition, novel mechanisms of regulating DDIs can also be suggested. In the case of the substance targeted for interaction, not only the DDIs but also the herb–drug or food–drug interactions have been reported to be clinically relevant in terms of adverse side effects. Reporting examples of drug interactions on a marketed drug or studies on new mechanisms will be very helpful for preventing the side effects of the patient taking these drugs. This Special Issue aims to highlight current progress in understanding both the clinical and nonclinical interactions of commercial drugs and the elucidation of the mechanisms of drug interactions.

Keywords

Research & information: general --- Biology, life sciences --- tadalafil --- ticagrelor --- drug-drug interaction --- pharmacokinetics --- plasma concentration --- CYP3A4 --- Loxoprofen --- CYP3A --- Dexamethasone --- Ketoconazole --- CYP2D6 --- O-desmethyltramadol --- physiologically-based pharmacokinetics --- tramadol --- (‒)-sophoranone --- CYP2C9 --- potent inhibition --- in vitro --- in vivo --- drug interaction --- low permeability --- high plasma protein binding --- biflavonoid --- cytochrome P450 --- drug interactions --- selamariscina A --- uridine 5′-diphosphoglucuronosyl transferase --- tissue-specific --- systemic exposure --- P-glycoprotein (P-gp) --- organic anion transporting polypeptide 1A2 (OATP1A2) --- Rumex acetosa --- fexofenadine --- chronic kidney disease --- drug–drug interactions --- polypharmacy --- adverse drug reactions --- Lexicomp --- subset analysis --- signal detection algorithms --- spontaneous reporting systems --- mechanism-based inhibition --- competitive inhibition --- non-competitive inhibition --- substrate --- inhibitor --- cytochromes P450 --- OATP1B1 --- OATP1B3 --- tyrosine kinase inhibitors --- drug-drug interactions --- migraine --- lasmiditan --- gepants --- monoclonal antibodies --- CYP1A1 --- CYP1A2 --- drug–drug interaction --- expression --- metabolism --- regulation --- drug transporter --- ubiquitination --- ixazomib --- DDI --- computational prediction --- in silico --- QSAR --- drug metabolism --- ADME --- CYP --- metabolic DDI --- P450 --- 1A2 --- 2B6 --- 2C19 --- 2C8 --- 2C9 --- 2D6 --- 3A4


Book
Drug-Drug Interactions
Authors: ---
Year: 2021 Publisher: Basel, Switzerland MDPI - Multidisciplinary Digital Publishing Institute

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Abstract

Drug–drug interactions (DDIs) cause a drug to affect other drugs, leading to reduced drug efficacy or increased toxicity of the affected drug. Some well-known interactions are known to be the cause of adverse drug reactions (ADRs) that are life threatening to the patient. Traditionally, DDI have been evaluated around the selective action of drugs on specific CYP enzymes. The interaction of drugs with CYP remains very important in drug interactions but, recently, other important mechanisms have also been studied as contributing to drug interaction including transport- or UDP-glucuronyltransferase as a Phase II reaction-mediated DDI. In addition, novel mechanisms of regulating DDIs can also be suggested. In the case of the substance targeted for interaction, not only the DDIs but also the herb–drug or food–drug interactions have been reported to be clinically relevant in terms of adverse side effects. Reporting examples of drug interactions on a marketed drug or studies on new mechanisms will be very helpful for preventing the side effects of the patient taking these drugs. This Special Issue aims to highlight current progress in understanding both the clinical and nonclinical interactions of commercial drugs and the elucidation of the mechanisms of drug interactions.

Keywords

Research & information: general --- Biology, life sciences --- tadalafil --- ticagrelor --- drug-drug interaction --- pharmacokinetics --- plasma concentration --- CYP3A4 --- Loxoprofen --- CYP3A --- Dexamethasone --- Ketoconazole --- CYP2D6 --- O-desmethyltramadol --- physiologically-based pharmacokinetics --- tramadol --- (‒)-sophoranone --- CYP2C9 --- potent inhibition --- in vitro --- in vivo --- drug interaction --- low permeability --- high plasma protein binding --- biflavonoid --- cytochrome P450 --- drug interactions --- selamariscina A --- uridine 5′-diphosphoglucuronosyl transferase --- tissue-specific --- systemic exposure --- P-glycoprotein (P-gp) --- organic anion transporting polypeptide 1A2 (OATP1A2) --- Rumex acetosa --- fexofenadine --- chronic kidney disease --- drug–drug interactions --- polypharmacy --- adverse drug reactions --- Lexicomp --- subset analysis --- signal detection algorithms --- spontaneous reporting systems --- mechanism-based inhibition --- competitive inhibition --- non-competitive inhibition --- substrate --- inhibitor --- cytochromes P450 --- OATP1B1 --- OATP1B3 --- tyrosine kinase inhibitors --- drug-drug interactions --- migraine --- lasmiditan --- gepants --- monoclonal antibodies --- CYP1A1 --- CYP1A2 --- drug–drug interaction --- expression --- metabolism --- regulation --- drug transporter --- ubiquitination --- ixazomib --- DDI --- computational prediction --- in silico --- QSAR --- drug metabolism --- ADME --- CYP --- metabolic DDI --- P450 --- 1A2 --- 2B6 --- 2C19 --- 2C8 --- 2C9 --- 2D6 --- 3A4

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