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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Drugs --- Therapeutic equivalency. --- Standards --- Bioequivalence in drugs --- Clinical equivalence in drugs --- Therapeutic equivalency in drugs --- Biopharmaceutics --- Equivalency, Therapeutic --- Pharmaceutical technology. --- Pharmaceutical Sciences/Technology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- United States. --- FDA --- F.D.A. --- U.S. Food & Drug Administration

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This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modeling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.   Vinod P. Shah is a pharmaceutical consultant. He was Scientific Secretary of the International Pharmaceutical Federation (FIP) and is now Chair of the FIP Regulatory Sciences Special Interest Group. Dr. Shah has served at the U.S. Food and Drug Administration and has developed several regulatory guidances for the pharmaceutical industry in biopharmaceutics and topical drug products. Howard I. Maibach is professor of dermatology at the University of California, San Francisco. He received his M.D. at Tulane University Medical School in New Orleans, Louisiana, and completed his residency and research fellowships at the University of Pennsylvania in Philadelphia, Pennsylvania. Professor Maibach is a leading authority in the fields of dermatotoxicology and dermatopharmacology, in which he has conducted research and written extensively. John Jenner is a principal scientist at The Defence Science and Technology Laboratory in the UK. He has a degree in pharmacology from the University of Manchester in Manchester, UK, and a Ph.D. from the University of Surrey, Guildford, UK. John has spent his career studying defense against and treatment of highly toxic chemicals. He has an enduring research interest in percutaneously active chemicals, whether toxic materials or drugs, and experience in the design and testing of transdermal formulations.

Therapeutics, Cutaneous and external. --- Bioavailability. --- Drugs --- Skin --- Therapeutic equivalency. --- Permeability. --- Cutaneous permeability --- Skin permeability --- Bioequivalence in drugs --- Clinical equivalence in drugs --- Therapeutic equivalency in drugs --- Biopharmaceutics --- Availability, Biological --- Biological availability --- Physiologic availability --- Physiological availability --- Biochemistry --- Cutaneous therapeutics --- Equivalency, Therapeutic --- Toxicology. --- Animal physiology. --- Pharmacology/Toxicology. --- Animal Physiology. --- Biological and Medical Physics, Biophysics. --- Animal physiology --- Animals --- Biology --- Anatomy --- Chemicals --- Medicine --- Pharmacology --- Poisoning --- Poisons --- Physiology --- Toxicology --- Pharmacology. --- Biophysics. --- Biological physics. --- Biological physics --- Medical sciences --- Physics --- Drug effects --- Medical pharmacology --- Chemotherapy --- Pharmacy --- Physiological effect --- Physiology.

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Drugs --- Oral medication. --- Pharmacokinetics. --- Biological Availability. --- Biopharmaceutics. --- Drug Therapy. --- Bioavailability. --- Absorption and adsorption. --- Therapy, Drug --- Chemotherapy --- Pharmacotherapy --- Chemotherapies --- Drug Therapies --- Pharmacotherapies --- Therapies, Drug --- Disease --- Pharmaceutical Preparations --- Pharmacologic Actions --- Pharmaceutics --- Pharmaceutic --- Chemistry, Pharmaceutical --- Availability, Biologic --- Availability, Biological --- Availability, Physiologic --- Biologic Availability --- Availability Equivalency --- Bioavailability --- Physiologic Availability --- Availabilities, Biologic --- Availabilities, Biological --- Availabilities, Physiologic --- Availability Equivalencies --- Bioavailabilities --- Biologic Availabilities --- Biological Availabilities --- Equivalencies, Availability --- Equivalency, Availability --- Physiologic Availabilities --- ADME --- ADME-Tox --- ADMET --- Absorption, Distribution, Metabolism, Elimination, and Toxicology --- Absorption, Distribution, Metabolism, and Elimination --- Drug Kinetics --- Kinetics, Drug --- LADMER --- Liberation, Absorption, Distribution, Metabolism, Elimination, and Response --- Drugs by mouth --- Medication, Oral --- Mouth, Medication by --- Peroral medication --- Therapeutics --- Drug bioavailability --- Biopharmaceutics --- drug therapy --- therapeutic use --- pharmacokinetics --- Administration --- Availability, Physiological --- Physiological availability

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Achievement tests play an important role in modern societies. They are used to evaluate schools, to assign students to tracks within schools, and to identify weaknesses in student knowledge. The GED is an achievement test used to grant the status of high school graduate to anyone who passes it. GED recipients currently account for 12 percent of all high school credentials issued each year in the United States. But do achievement tests predict success in life? The Myth of Achievement Tests shows that achievement tests like the GED fail to measure important life skills. James J. Heckman, John Eric Humphries, Tim Kautz, and a group of scholars offer an in-depth exploration of how the GED came to be used throughout the United States and why our reliance on it is dangerous. Drawing on decades of research, the authors show that, while GED recipients score as well on achievement tests as high school graduates who do not enroll in college, high school graduates vastly outperform GED recipients in terms of their earnings, employment opportunities, educational attainment, and health. The authors show that the differences in success between GED recipients and high school graduates are driven by character skills. Achievement tests like the GED do not adequately capture character skills like conscientiousness, perseverance, sociability, and curiosity. These skills are important in predicting a variety of life outcomes. They can be measured, and they can be taught. Using the GED as a case study, the authors explore what achievement tests miss and show the dangers of an educational system based on them. They call for a return to an emphasis on character in our schools, our systems of accountability, and our national dialogue. Contributors Eric Grodsky, University of Wisconsin-Madison Andrew Halpern-Manners, Indiana University Bloomington Paul A. LaFontaine, Federal Communications Commission Janice H. Laurence, Temple University Lois M. Quinn, University of Wisconsin-Milwaukee Pedro L. Rodríguez, Institute of Advanced Studies in Administration John Robert Warren, University of Minnesota, Twin Cities

GED tests. --- Academic achievement --- Educational tests and measurements --- Personality development. --- Character development --- Character formation --- Development, Character --- Development, Personality --- Formation, Character --- Child psychology --- Educational assessment --- Educational measurements --- Mental tests --- Tests and measurements in education --- Psychological tests for children --- Psychometrics --- Students --- Examinations --- Psychological tests --- Academic performance --- Academic progress --- Academic success --- Academic underachievement --- Achievement, Academic --- Achievement, Scholastic --- Achievement, Student --- Educational achievement --- Performance, Academic --- Progress, Academic --- Scholastic achievement --- Scholastic success --- School achievement --- School success (Academic achievement) --- Student achievement --- Success, Academic --- Success, School (Academic achievement) --- Success, Scholastic --- Underachievement, Academic --- Performance --- Success --- General educational development tests --- High school equivalency examinations --- Testing --- Standards --- Rating of --- GED tests --- Personality development --- E-books --- Didactic evaluation --- ged, high school diploma, education, standardized tests, academic achievement, testing, character, success, economics, earning potential, poverty, ses status, family support, college, work, employment, health, conscientiousness, perseverance, sociability, curiosity, accountability, graduation, military, cognition, drop out, nonfiction, sociology, pedagogy, first generation.