Drug Efficacy Study

Author by : National Research Council (U.S.). Division of Medical Sciences
Languange : en
Publisher by : Unknown
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Total Read : 90
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Drug Efficacy Study

Author by : Anonim
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 84
Total Download : 757
File Size : 44,8 Mb
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Drugs For Veterinary Use

Author by : United States. Food and Drug Administration
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 36
Total Download : 592
File Size : 49,9 Mb
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Drug Efficacy Study

Author by : National Research Council (U.S.). Division of Medical Sciences
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 27
Total Download : 976
File Size : 43,6 Mb
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Description :


Drug Efficacy Study

Author by : Anonim
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 28
Total Download : 371
File Size : 51,9 Mb
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Approved Drug Products With Therapeutic Equivalence Evaluations

Author by : Barry Leonard
Languange : en
Publisher by : DIANE Publishing
Format Available : PDF, ePub, Mobi
Total Read : 70
Total Download : 779
File Size : 41,8 Mb
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Description : Identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.


Approved Drug Products With Therapeutic Equivalence Evaluations

Author by : Barry Leonard
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 52
Total Download : 380
File Size : 50,6 Mb
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Description : Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.


Chronological Document Listing 1936 1976

Author by : United States. Food and Drug Administration
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 36
Total Download : 816
File Size : 51,9 Mb
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Approved Drug Products With Therapeutic Equivalence Evaluations

Author by : DIANE Publishing Company
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 20
Total Download : 373
File Size : 52,9 Mb
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Description : Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.


Approved Drug Products With Therapeutic Equivalence Evaluations 2003

Author by : Barry Leonard
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 14
Total Download : 269
File Size : 40,7 Mb
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Description : Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multi-source prescription drug products.


Drug Efficacy

Author by : United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 96
Total Download : 984
File Size : 47,6 Mb
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Synchronized Multi Material Bioprinting Of Hetero Cellular Models To Study Drug Efficacy In Co Culture

Author by : Jessica Elizabeth Snyder
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 12
Total Download : 222
File Size : 52,5 Mb
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Description : Bottom-up tissue engineering pursues automated process control over human tissue fabrication using the fundamental cellular, soluble, and architectural components as the working material. Key technology for methodological progress of bottom-up tissue engineering includes advanced biofabrication techniques to assemble viable biological material in 3-dimensional space and microfluidic devices to control timing and sequence of environmental stimulation. The presented research's objective is the development of design, characterization and fabrication approaches which integrate physiologically relevant microfluidic techniques and hetero-cellular architecture for cell-laden models by leveraging combinations of the biofabrication techniques; including precision extrusion deposition, multi-nozzle cell printing, replica molding, and a novel synchronized multi-material bioprinting system. This research focuses on the development of a synchronized multi-material bioprinter for the fabrication of 3D hetero-cellular models. The specific research objectives are: (1) combine multi-nozzle deposition system with a microlfuidic platform for controlled cell seeding in a microfluidic device for a hetero-cellular in vitro model for drug testing, (2) to define a 3D printing and replica molding processes to fabricate microfluidic and scaffold environments with control of the macro-scale (10-3-10-1 m) patterning of channels/structural elements and micro-scale (10-4-10-3 m) channel cross-section of internal features, (3) to develop and characterize an integrated synchronized multi-material bioprinter system to produce nano-liter droplets and 10-4-10-3 m diameter filaments with a heterogeneous packaging resolution of 10-5-10-3 m, and (4) to apply the synchronized multi-material bioprinter system to produce hetero-cellular models to study radioprotective drug efficacy in co-culture and metabolism rates in simulated weightlessness environments. The presented biofabrication methods are applied to fabricate a hetero-cellular liver model to study drug efficacy of the pro-drug amifostine to shield liver from radiation genetic damage and pharmacokinetic up-take in model microgravity.


New Drug Development

Author by : J. Rick Turner
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 73
Total Download : 851
File Size : 46,5 Mb
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Description : New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.


The Parent Child Experience Of Taking Oral Glutamine In A Research Study

Author by : Diana L. Barr
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 45
Total Download : 197
File Size : 45,6 Mb
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Description : Oral mucositis, an inflammatory and ulcerative condition is an unfortunate and costly side effect of cancer treatment. Conflicting reports exist regarding the efficacy of various treatments and preventive measures. This qualitative study explored the experience of two parents whose child participated in an oral glutamine research study at a large midwestern medical center. The purpose of this study was to explore the experience of parents after their child participated in a drug efficacy trial.


Clinical Trials

Author by : Tom Brody
Languange : en
Publisher by : Academic Press
Format Available : PDF, ePub, Mobi
Total Read : 12
Total Download : 856
File Size : 48,5 Mb
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Description : Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers


Drugs Compromising Male Sexual Health

Author by : Walter K.H. Krause
Languange : en
Publisher by : Springer Science & Business Media
Format Available : PDF, ePub, Mobi
Total Read : 61
Total Download : 436
File Size : 43,8 Mb
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Description : This concise drug guide lists 500 substances, such as pharmaceutical drugs, lifestyle drugs, and environmental toxicants, which show documented untoward effects on the male sexual organs and their functions. All substances are listed in user-friendly alphabetical order with a uniform structure throughout the book. Each listing includes evidence-based information with up-to-date references and all studies mentioned are evaluated and categorized according to study and sample types. This unique compendium provides more detailed information on each drug than any other standard pharmacology title.


Antiviral Drugs

Author by : Wieslaw M. Kazmierski
Languange : en
Publisher by : John Wiley & Sons
Format Available : PDF, ePub, Mobi
Total Read : 91
Total Download : 346
File Size : 42,5 Mb
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Description : This book focuses on new small molecule approaches to combat viral infections. The chapters describe the discovery and development from bench through the clinic of relatively recently-approved antiviral drugs and compounds in advanced clinical development. Organized by a virus (such as HIV, HCV, RSV, influenza, HBV and CMV) and written by top academic and industrial authorities in the field, the book provides a unique opportunity to study, understand and apply discovery and development principles and learning without the need for an individual to research, analyze and synthesize all immense sourcing references. Topics showcase challenges and solutions of issues encountered, offering tremendous experience accumulated over many years of research that will be particularly useful to basic and bench scientists as well as clinicians as they continue discovering and developing new drugs and therapies.


Predictive Toxicology In Drug Safety

Author by : Jinghai J. Xu
Languange : en
Publisher by : Cambridge University Press
Format Available : PDF, ePub, Mobi
Total Read : 57
Total Download : 217
File Size : 55,8 Mb
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Description : According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment and promotes evidence-based toxicology. Each specific area of toxicology relevant for drug discovery is discussed in detail, including theory, experimental approaches and data interpretation supported by comprehensive up-to-date references. Many chapters provide fascinating case studies, which are of general interest for those who have basic science training and are interested in how chemicals interact with the human body.


Information Learning And Drug Diffusion

Author by : Pradeep Chintadunta
Languange : en
Publisher by : Unknown
Format Available : PDF, ePub, Mobi
Total Read : 33
Total Download : 682
File Size : 47,7 Mb
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Description : The recent withdrawal of Cox-2 Inhibitors has generated debate on the role of information in drug diffusion: can the market learn the efficacy of new drugs, or does it depend solely on manufacturer advertising and FDA updates? In this study, we use a novel data set to study the diffusion of three Cox-2 Inhibitors - Celebrex, Vioxx and Bextra - before the Vioxx withdrawal. Our study has two unique features: first, we observe each patient?s reported satisfaction after consuming a drug. This patient level data set, together with market level data on FDA updates, media coverage, academic articles, and pharmaceutical advertising, allows us to model individual prescription decisions. Second, we distinguish across-patient learning of a drug's general efficacy from the within-patient learning of the match between a drug and a patient. Our results suggest that prescription choice is sensitive to many sources of information. At the beginning of 2001 and upon Bextra entry in January 2002, doctors held a strong prior belief about the efficacy of Celebrex, Vioxx, and Bextra. As a result, the learning from patient satisfaction is gradual and more concentrated on drug-patient match than on across-patient spillovers. News articles are weakly beneficial for Cox-2 drug sales, but academic articles appear to be detrimental. The impact of FDA updates is close to zero once we control for academic articles, which suggests that FDA updates follow academic articles and therefore deliver little new information to doctors. We find that drug advertising also influences the choice of a patient's medication. A number of counterfactual experiments are carried out to quantify the influence of information on market shares.


Pharmacogenetics Kinetics And Dynamics For Personalized Medicine

Author by : David F. Kisor
Languange : en
Publisher by : Jones & Bartlett Publishers
Format Available : PDF, ePub, Mobi
Total Read : 16
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File Size : 44,8 Mb
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Description : Pharmacogenetics, Kinetics, and Dynamics for Personalized Medicine provides a primer to understand pharmacogenetics (the study of genetic factors that influence how a drug works) in the applied context of pharmacokinetics (how the body handles a drug) and pharmacodynamics (the effects of a drug on the body). This valuable foundation illuminates how these principles and scientific advances can create optimal individual patient care, that is, personalized medicine. Through specific drug examples, this resource explores how the genetic constitution of an individual may lead to the need for an altered dose or in some cases alternative drug therapy. Real-world cases highlight the specific relationships between genetics, drug action, and the body s response as well as adverse drug reactions, altered metabolism, and drug efficacy. Ethical issues concerning pharmacogenomics and study design are also discussed in this concise overview."