Search result: Catalogue data in Autumn Semester 2018
Pharmaceutical Sciences Master | ||||||
Core Courses I | ||||||
Number | Title | Type | ECTS | Hours | Lecturers | |
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535-0030-00L | Therapeutic Proteins | O | 3 credits | 3G | C. Halin Winter, D. Neri | |
Abstract | In this course, various topics related to the development, GMP production and application of therapeutic proteins will be discussed. Furthermore, students will expand their training in pharmaceutical immunology and will be introduced to the basic concepts of pharmaceutical product quality management. | |||||
Objective | Students know and understand: - basic mechanisms and regulation of the immune response - the pathogenic mechanisms of the most important immune-mediated disorders - the most frequently used expression systems for the production of therapeutic proteins - the use of protein engineering tools for modifying different features of therapeutic proteins - the mechanism of action of selected therapeutic proteins and their application - basic concepts in the GMP production of therapeutic proteins | |||||
Content | The course consists of two parts: In a first part, students will complete their training of pharmaceutical immunology (Chapter 13 - 16 Immunobiology VIII textbook). This part particularly focuses on the pathogenic mechanisms of immune-mediated diseases. Deepened knowledge of immunology will be relevant for understanding the mechanism of action of many therapeutic proteins, as well as for understanding one major concern related to the use of protein-based drugs, namely, immunogenicity. The second part focuses on topics related to the development and application of therapeutic proteins, such as protein expression, protein engineering, reducing immunogenicity, and GMP production of therapeutic proteins. Furthermore, selected examples of approved therapeutic proteins will be discussed. | |||||
Lecture notes | Handouts to the lectures will be available for downloading under Link | |||||
Literature | - Janeway's ImmunoBiology, by Kenneth Murphy (9th Edition), Chapters 12-16 - Lecture Handouts - Paper References provided in the Scripts - EMEA Dossier for Humira | |||||
535-0041-00L | Pharmacology and Toxicology III | O | 2 credits | 2G | M. Detmar, U. Quitterer | |
Abstract | The course is divided into two parts. The first part provides a detailed understanding of drugs and pharmacotherapy of infectious diseases and cancer. The second part gives an overview of the field of pharmacogenomics with a special focus on the role of genetic polymorphisms in disease susceptibility, drug response and adverse effects. | |||||
Objective | The course advances basic knowledge in pharmacology and toxicology. Special emphasis is placed on the interrelationship between pharmacological, pathophysiological and clinical aspects of drug therapy in the fields of infectious diseases and cancer. The course also provides an overview of the field of pharmacogenomics, with a special focus on the role of genetic polymorphisms in disease susceptibility, drug response and adverse effects. | |||||
Content | Topics include the pharmacology and pharmacotherapy of infectious diseases and cancer. In the field of pharmacogenomics, the course is focused on genetics, genome-wide association studies, genetic disease predisposition, examples of genetic variability of drug metabolism and drug responses, identification of new drug targets, relevance of pharmacogenomics for clinical drug development, and toxicogenomics. | |||||
Lecture notes | A script is provided for each lecture course. The scripts define important and exam-relevant contents of lectures. Scripts do not replace the lecture. | |||||
Literature | Recommended reading: The classic textbook in Pharmacology: Goodman and Gliman`s The Pharmacological Basis of Therapeutics Laurence Brunton, Bjorn Knollman, Randa Hilal-Dandan. 13th edition (2017) ISBN-10: 1259584739 ISBN-13: 978-1259584732 or Klaus Aktories, Ulrich Förstermann, Franz Hofmann, Klaus Starke. Allgemeine und spezielle Pharmakologie und Toxikologie. 12th edition (2017) Urban & Fischer (Elsevier, München) ISBN-13: 978-3-437-42527-7 | |||||
535-0050-00L | Pharmacoepidemiology and Drug Safety | O | 3 credits | 2G | S. Russmann | |
Abstract | Introduction to the principles, methods and applications of pharmacoepidemiology and drug safety. Drug safety in the pharmaceutical industry and regulatory authorities, but also for hospital and office pharmacists. Another focus is the evaluation and interpretation of pharmacoepidemiological drug safety studies in the medical literature and the evaluation of benefits vs. risks. | |||||
Objective | Objectives: - To familiarize participants with the principle methods and applications of pharmacoepidemiology and drug safety that is relevant for industry, regulatory affairs, but also for clinical pharmacists in hospitals and office pharmacies. - Perform independently a causality assessment of suspected adverse drug reactions in patients - Study designs and biostatistics used for the quantitative evaluation of drug safety - Setup of programs that can effectively reduce medication errors and improve drug safety in clinical practice, particularly in hospitals | |||||
Content | - Historical landmarks of drug safety - Pharmacovigilance and causality assessment - Drug safety in premarketing clinical trials - Descriptive, cohort and case-control drug safety study designs; Data analysis and control of confounding - Pharmacoepidemiology and regulatory decision making in drug safety; Risk management plans (RMPs) - Medication errors, clinical pharmacology / clinical pharmacy - Clinical Decision Support Systems, Interventional Pharmacoepidemiology - Pharmacoepidemiological databases, 'Big Data' - Interactive discussion of many real-life examples for each topic | |||||
Lecture notes | This course will be a combination of formal lectures, group discussions and self-directed studies. Course material will be taught through seminars, case studies in small groups. Reading material and scripts will be provided for each week. | |||||
Literature | Recommended literature - Rothman: Introduction to Epidemiology - Strom, Kimmel, Hennessy: Textbook of Pharmacoepidemiology - Gigerenzer: Risk Savvy - How to Make Good Decisions | |||||
535-0546-00L | Patents | O | 1 credit | 1V | A. Koepf, P. Pliska | |
Abstract | Knowledge in the field of intellectual property, especially of patents and trademarks, with particular emphasis on pharmaceutics. Introduction into intellectual property; prosecution of patent applications; patent information; exploitation and enforcement of patents; peculiarities in pharmaceutics and medicine; social, political and ethical aspects; Trademarks. | |||||
Objective | Basic knowledge in the field of industrial property, especially of patents and trademarks, with particular emphasis on the chemical, pharmaceutical and biotech field. | |||||
Content | 1. Introduction into industrial property (patents, trademarks, industrial designs); 2. Prosecution of patent applications (patentability); 3. Patent information (patent publications, databases, searches); 4. Exploitation and enforcement of patents (possibilities of exploitation, licenses, parallel imports, scope of protection, patent infringement); 5. Peculiarities in pharmaceutics and medicine (supplementary protection certificates, experimental use exemption, therapy and diagnosis, medical indication); 6. Social, political and ethical aspects (patents and prices for medicinal products, traditional knowledge and ethnomedicine, bioprospecting and biopiracy, human DNA inventions); 7. Trademarks, types of trademarks, grounds for refusal, peculiarities of pharma-trademarks. | |||||
Lecture notes | A script is provided in electronic form during the lecture. | |||||
Literature | - Swiss Patents Act: Link - Swiss Trademarks Act: Link - Swiss Industrial-Designs Act: Link - European Patent Convention: Link - Patent Cooperation Treaty: Link - Swiss Federal Institute of Intellectual Property: Link - European Patent Office: Link - World Intellectual Property Organization: Link | |||||
511-0000-00L | Drug Discovery and Development Only for Pharmaceutical Sciences MSc. | O | 2 credits | 2G | U. Thibaut, J. Hall | |
Abstract | This course provides an overview over the concepts and processes employed in today's drug discovery and development. It has an introductory character but will also provide more detailed insights employing real life examples. The course combines lectures and interactive elements with active participation of the students. | |||||
Objective | Students - Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes). - Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria. - Understand the concepts underlying drug product development through all the phases from preclinical and clinical development to regulatory submission, approval and market launch. - Can differentiate between small molecule drug development and biological drug development. - Understand the most important differences between legal and regulatory requirements for drug development and approval for the major markets EU and USA. | |||||
Content | Drug Discovery (day 1): Introduction to drug discovery: the concepts of drug target selection, ligands/leads, the developability of drug candidates; Overview over the principal approaches to drug discovery: rational drug design, the natural product approach, serendipity, repurposing as well as chemical libraries and high-throughput screening. Drug Development (days 2 and 3): Introduction to the industrial drug product development processes covering the following phases: preclinical research and development, clinical development, regulatory processes and market launch. R&D support processes such as project management, quality management, pharmacovigilance and pharmacoeconomics will be covered as well as organizational and governance aspects of the pharmaceutical industry. | |||||
Lecture notes | Will be published on "mystudies" | |||||
Literature | G. Nahler (Hrsg.) Dictionary of pharmaceutical medicine, Springer, Wien, 2013 (3rd edition) Further readings will be listed in the lecture notes. | |||||
Prerequisites / Notice | This course provides the essential basic knowledge required for the industry-specific modules of the spring semester. | |||||
511-0007-00L | Scientific Writing and Presenting Only for Pharmaceutical Sciences MSc. | O | 2 credits | 2G | G. Schneider, J. Dolenc, J. A. Hiss, J.‑C. Leroux, O. Renn, J. Schnabl | |
Abstract | This introductory class provides an overview of the basic scientific writing techniques and a guideline to presenting scientific data, together with guided exercises and hands-on training. It is devised to accompany the research projects within the curriculum of the MSc in Pharmaceutical Sciences. | |||||
Objective | The class enables the participants to prepare their own scientific texts and oral presentations, and critically assess the quality of the presentation of scientific data. | |||||
Content | The participants receive an introduction to basic formal aspects of scientific writing and the design of graphical elements. Lectures and topical seminars alternate with practical task for the participants, which will be evaluated in a peer-to-peer setting. Performance feedback is provided by both the teachers and the peers. | |||||
Electives I | ||||||
Number | Title | Type | ECTS | Hours | Lecturers | |
535-0011-00L | Drug Seminar The course is reserved for students registered in the Master's programme in Pharmacy or in Pharmaceutical Sciences | W | 5 credits | 9S | M. Detmar, K.‑H. Altmann, S. M. Ametamey, B. A. Gander, C. Halin Winter, J. Hall, S.‑D. Krämer, J.‑C. Leroux, C. Müller, D. Neri, V. I. Otto, U. Quitterer, R. Schibli, G. Schneider, C. Steuer, H. U. Zeilhofer | |
Abstract | The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences. Students work in small groups on a chosen topic, they write a mini-review and present their work on a one day symposium. | |||||
Objective | The main objectives of this course are: - students develop their scientific reflection (Critical Thinking) and working skills by working independently on a relevant pharmaceutical topic - students gain in-depth knowledge of the topic investigated - students train their scientific writing and presentation skills - students train their ability to plan a project and work in a team | |||||
Content | The Course Drug Seminar takes place during the first 7 weeks of the 1. Master semester. It is a compulsory course of the MSc Pharmacy curriculum and an elective course in the MSc PharmSciences. The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences. During the course, students work in small teams on a topic of their choice and elaborate a written mini-review and an oral presentation. Each team is tutored by a lecturer of the Institute of Pharmaceutical Sciences. The work is mainly based on literature search / review, but may also involve conducting interviews or site visits, if appropriate. The final presentations of all groups will take place in the framework of a dedicated Symposium held in the middle of the semester. | |||||
Prerequisites / Notice | Only for students of MSc Pharmacy and MSc Pharmaceutical Sciences. | |||||
511-1001-00L | Biopharmacy (Crash Course) Only for Pharmaceutical Sciences MSc. Obligatory course if assigned by the Admission committee. | E- | 2 credits | 1S | S.‑D. Krämer | |
Abstract | This course provides the basic concepts of biopharmacy (ADMET, absorption, distribution, metabolism, excretion, toxicity of drugs) and pharmacokinetics. After an introduction to the fundamental parameters and concepts, the participants will study independently and apply and consolidate their knowledge in tutorials. | |||||
Objective | - Knowledge of the ADMET processes and the respective pharmacokinetic parameters. - Interpretation of pharmacokinetic parameters. - Analysis of drug plasma concentration-time curves. - Prediction of pharmacokinetic parameters based on in vitro assays and physicochemical drug properties. - Knowledge of the effects of physiological factors on the pharmacokinetic parameters and on drug plasma and tissue concentrations. - Design of dosage regimens, based on pharmacokinetic parameters. - Prediction of drug-drug interaction potentials based on in vitro assays and pharmacokinetic parameters. | |||||
Content | - Introduction to biopharmacy (ADMET) and pharmacokinetics. - Definition of the most important pharmacokinetic parameters and their calculation from plasma concentration-time curves. - Introduction to compartment models, statistical models, physiological models. - Pharmacokinetic profiling of drugs for therapy optimization and for the analysis of the interaction potential. - Design of dosage regimens. In vitro assays to predict pharmacokinetic parameters. | |||||
Lecture notes | Slides, see documents repository. | |||||
Literature | Dennis A. Smith, Charlotte Allerton, Amit S. Kalgutkar, Han van de Waterbeemd, Don K. Walker (Eds.) Pharmacokinetics and Metabolism in Drug Design. 3rd edition, 2012. Wiley online library. DOI: 10.1002/9783527645763 Link | |||||
Prerequisites / Notice | *** | |||||
511-1002-00L | Pharmaceutical Analytics and Pharmacopeia (Crash Course) Only for Pharmaceutical Sciences MSc. Obligatory course if assigned by the Admission committee. | E- | 2 credits | 1S | C. Steuer | |
Abstract | This course provides the basic concepts of pharmaceutical analytics in the context of pharmacopeial regulation. After an introduction to the fundamental techniques and concepts, the participants will study independently, apply and consolidate their knowledge in tutorials. | |||||
Objective | Students are able to: summarize the structure of the Ph. Eur. summarize the most important pharmacopeias and their communalities and differences discuss the structure of a monograph explain qualification of instruments and validation of methods explain and compare most important analytical techniques for pharmaceutical industry | |||||
Content | Students gain knowledge in pharmaceutical analytics to fulfill regulatory requirements in pharmaceutical industry based on the pharmacopeia in force. Focus is set on method validation, equipment qualification, identification, purity testing and content determination of active pharmaceutical ingredients and excipients. | |||||
Lecture notes | Slides, see documents repository | |||||
Literature | Introduction to Pharmaceutical Chemical Analysis, Steen Honoré Hansen, Stig Pedersen-Bjergaard, Knut Rasmussen ISBN: 978-0-470-66121-5 , DOI: 10.1002/9781119953647, free download for eth students | |||||
511-1003-00L | Gene Technology (Crash Course) Only for Pharmaceutical Sciences MSc. Obligatory course if assigned by the Admission committee. | E- | 1 credit | 1S | J. Scheuermann | |
Abstract | The course enables the student to understand and and apply the general concepts of gene technology, including recombinant DNA technology and its application in genomics, transcriptomics and proteomics. Protein cloning, expression and modifications and bimolecular interactions will be discussed. The concept of display technology and its applications in the field of drug discovery will be presented. | |||||
Objective | The students remember and understand: 1. The tools of recombinant DNA technology 2. Next generation sequencing approaches and their relevance for -omics projects 3. Protein cloning, expression, modification/labelling and oligomerization 4. Thermodynamic and kinetic affinity constants in bimolecular reactions 5. Basic structure of the antibody molecule 6. Concepts of antibody phage technology and antibody engineering 7. Construction of antibody-, peptide- or small molecule libraries and affintiy-based selection methodologies | |||||
Content | I) Genomics: recombinant DNA technology methods to sequence genomes application to human biology Transcriptomics / Proteomics II) Proteins: protein cloning and expression homo- and heterodimerization chemical modifications and radioactive labelling detection of bimolecular interactions affinity constant and experimental measurement kinetic association and dissociation constants III) Display technology: the antibody molecule, CDRs, basics of antibody engineering antibody phage display and selection methodologies construction of antibody libraries other display technologies (peptide display, DNA-encoded chemical libraries) | |||||
Lecture notes | slides and script used for the course and literature for reading and discussions will be made available online. | |||||
Literature | dedicated chapters of: S.B. Primrose and R.M. Twyman 'Principles of Gene Manipulation and Genomics', 7th ed. (2006) Blackwell Science | |||||
Prerequisites / Notice | admission to MSc in Pharmaceutical Sciences | |||||
535-0423-00L | Drug Delivery and Drug Targeting | W | 2 credits | 1.5V | J.‑C. Leroux, B. A. Gander, A. Spyrogianni Roveri | |
Abstract | The students gain an overview on current principles, methodologies and systems for controlled delivery and targeting of drugs. This enables the students to understand and evaluate the field in terms of scientific criteria. | |||||
Objective | The students dispose of an overview on current principles and systems for the controlled delivery and targeting of drugs. The focus of the course lies on developing a capacity to understand the involved technologies and methods, as well as an appreciation of the chances and constraints of their therapeutic usage, with prime attention on anticancer drugs, therapeutic peptides, proteins, nucleic acids and vaccines. | |||||
Content | The course covers the following topics: drug targeting and delivery principles, macromolecular drug carriers, liposomes, micelles, micro/nanoparticles, gels and implants, administration of vaccines, targeting at the gastrointestinal level, synthetic carriers for nucleic acid drugs, ophthalmic devices and novel trends in transdermal and nasal drug delivery. | |||||
Lecture notes | Selected lecture notes, documents and supporting material will be directly provided or may be downloaded using Link The website also displays additional information on peroral delivery systems, transdermal systems and systems for alternative routes (nasal, pulmonary) of delivery. These fields are covered in detail in the course Galenische Pharmazie II (Galenical Pharmacy II). | |||||
Literature | A.M. Hillery, K. Park. Drug Delivery: Fundamentals & Applications, second edition, CRC Press, Boca Raton, FL, 2017. B. Wang B, L. Hu, T.J. Siahaan. Drug Delivery - Principles and Applications, second edition, John Wiley & Sons, Hoboken NJ, 2016. Y. Perrie, T. Rhades. Pharmaceutics - Drug Delivery and Targeting, second edition, Pharmaceutical Press, London and Chicago, 2012. Further references will be provided in the course. | |||||
535-0250-00L | Biotransformation of Drugs and Xenobiotics | W | 1 credit | 1V | S.‑D. Krämer | |
Abstract | Knowledge of the major reactions of biotransformation in drug therapy, prediction of possible metabolites of drugs and xenobiotics, recognition of structure elements and reactions which can lead to toxic metabolites. Knowledge of inter- and intraindividual factors influencing metabolism. | |||||
Objective | Goals: knowledge of the major reactions of biotransformation in drug therapy, prediction of possible metabolites of drugs and xenobiotics, recognition of structure elements and reactions which can lead to toxic metabolites. Knowledge of inter- and intraindividual factors influencing metabolism. | |||||
Content | Major reactions of biotransformation. Major enzymes and reaction partners involved in the biotransformation of drugs and xenobiotics. Toxic reactions of metabolites. Factors which affect the biotransformation. | |||||
Lecture notes | Biotransformation of drugs and xenobiotics | |||||
Literature | B. Testa and S.D. Krämer. The Biochemistry of Drug Metabolism: Volumes 1 and 2, VHCA, Zürich, 2008 and 2010. B. Testa and S.D. Krämer. The Biochemistry of Drug Metabolism: Parts 1 to 7. Published in Chemistry & Biodiversity, 2006-2009. | |||||
535-0015-00L | History of Pharmacy | W | 1 credit | 1V | M. Fankhauser | |
Abstract | The students will receive the basic knowledge of the history of pharmacy. This knowledge will allow them to have a detailled approach to the actual pharmacy and the development of the materia medica. | |||||
Objective | The students will receive the basic knowledge of the history of pharmacy. This knowledge will allow them to have a detailled approach to the actual pharmacy and the development of the materia medica. | |||||
Content | In the first part of the lecture we will talk about the position of the pharmacist in the past and in society. We go through the milestones of the social and legal development of pharmacy. The second part will deal with the history of pharmacology with development of therapeuctical theories and the evolution of the used remedies. It also includes their sometimes mystical and symbolical dimension. | |||||
Literature | Wird in der ersten Veranstaltung mitgeteilt. | |||||
Prerequisites / Notice | Voraussetzungen: Keine. Interesse für die Rolle der Pharmazie und der Medikamente in der Vergangenheit von Vorteil. | |||||
535-0344-00L | From Ethnopharmacy to Molecular Pharmacognosy | W | 1 credit | 1V | B. Frei Haller, J. Gertsch | |
Abstract | Basic understanding and awareness of ethnopharmaceutical and ethnopharmacological issues and research. Knowledge of methods used in drug discovery from natural sources. Discussion of the issues around law and international treaties. Importance of ethnopharmaceutical knowledge for world health. | |||||
Objective | Basic understanding and awareness of ethnopharmaceutical and ethnopharmacological issues and research. Knowledge of methods used in drug discovery from natural sources. Discussion of the issues around law and international treaties. Importance of ethnopharmaceutical knowledge for world health. | |||||
Content | Introduction into ethnopharmacy and related disciplines: definitions of terms, working methods, research projects, bioprospecting. Traditional medicinal plants of different cultures and their role in modern Western medicine (rational application of traditional uses), today's "fashion plants." Empirical, traditional knowledge versus Evidence Based Medicine. The role of biodiversity (CBD, Rio 1992; Nagoya, 2010) and problems associated with drug discovery from natural products. Screening strategies for drug discovery (random screening versus screening based on cultural, ecological, ethnopharmacological, chemotaxonomic criteria). Traditional knowledge in relation to the fight against malaria and its implementation in research, product development and development cooperation. Introduction to and selected examples of herbal drugs and poisons, mode of action, and their ethnopharmacological importance. Critical analysis of bioprospecting as a drug discovery strategy. | |||||
Lecture notes | Handouts will be provided. | |||||
Literature | Plants in Our World, Economic Botany (2014) Beryl B. Simpson; Molly Conner Ogorzaly, 4th ed. , MacGraw-Hill, Boston | |||||
Prerequisites / Notice | Prerequisites: Basic lectures in biology or biochemistry and pharmaceutical biology have been attended; not suitable for first semester students. | |||||
535-0310-00L | Glycobiology in Drug Development | W | 1 credit | 1V | V. I. Otto | |
Abstract | Protein-based drugs constitute around 25% of new approvals and most of them are glycoproteins. Using selected examples of prominent glycoprotein drugs, the course aims at providing insight into glycosylation-activity relationships and into biotechnological production and analytics. | |||||
Objective | Students gain insight into the glycobiology of therapeutically used glycoproteins. This implies knowing and understanding - the major types of protein-linked glycans and their biosynthesis - the most important expression systems for production of recombinant glycoproteins - methods used to alter or manipulate glycosylation - the most prominent clinically used glycoproteins and how glycosylation influences their therapeutic profile. - Current methods for the qualitative and quantitative characterization of glycoproteins Students are able to apply this knowledge and propose solutions to biotechnological problems that involve protein glycosylation. | |||||
Content | lecture plan: 1. Glycans - information carriers in biology and pharmacotherapy 2. Glucocerebrosidase and the biosynthesis of N-glycans 3. Glyocerebrosidase - production and quality control 4. Improving the therapeutic profile of monoclonal antibodies by glycoengineering 5. Sialylation and mucin-type O-glycans as critical quality attributes of glycoprotein hormones and drugs 6. EPO "the same but different" The lectures will include some exercises in which students apply their knowledge to solve simple biotechnological problems related to protein glycosylation. | |||||
Lecture notes | The slides used for the lectures will be provided online | |||||
Literature | - Essentials of Glycobiology 3rd edition, A. Varki, R.D. Cummings et al., Cold Spring Harbor Laboratory Press, New York 2017. - Posttranslational Modification of Protein Biopharmaceuticals, G. Walsh (ed.), Wiley VCH, Weinheim 2009. - Gentechnik, Biotechnik. Grundlagen und Wirkstoffe, 2. Auflage, Dingermann, Winckler, Zündorf, Wissenschaftliche Verlagsgesellschaft Stuttgart, 2011. | |||||
Prerequisites / Notice | Requirements: Basic knowledge in immunology, molecular biology, protein chemistry and analytics. Basic knowledge in pharmacology. | |||||
535-0300-00L | Molecular Mechanisms of Drug Actions and Targets Number of participants limited to 24. | W | 2 credits | 1V | J. Scheuermann | |
Abstract | On average one drug per year is withdrawn from the market. Using selected examples of such drug failures, the course aims at analyzing and discussing the present explanations of drug actions as well as the design and predictive power of animal models and clinical trials. In addition, the ethical, societal, and economical expectations in new drugs shall be reflected and discussed. | |||||
Objective | To develop a critical understanding of the relevance and limitations of the current approaches to explaining and anticipating drug effects. To critically appraise the ethical, societal, economical and political expectations in the development of new drugs. | |||||
Content | In December 2006, Pfizer stopped a large phase III study on the use of Torcetrapib for the prevention of atherosclerosis and cardiovascular disease. 800 million $ in development costs and 21 billion $ in stocks were annihilated overnight. The failure of Torcetrapib has pinpointed the limitations of an extremely reductionist view of atherosclerosis and it's prevention by drug therapy. It has also highlighted what high expectations we have in a safe and wide applicability of drugs and of their economical success. Torcetrapib is not a single case. In the last 10 years, on average one drug per year was withdrawn from the market due to lack of efficacy, unexpected side effects or toxicity. This clearly shows that the common investigations and the modern understanding of drug actions are often not sufficient to predict the effects a drug will have in large patient populations. These are the topics of the present course. Using three particularly informative examples of drug failures, the problems encountered and the concepts and informative value of preclinical and clinical studies will be analyzed and discussed. Furthermore, the ethical, societal, economical and political expectations in new drugs shall be reflected. | |||||
Lecture notes | Printouts of the slides used for the lectures and literature for reading and discussions will be available online. | |||||
Literature | Recommended reading: John Abramson, Overdo$ed America, Harper Perennial, New York 2008 | |||||
Prerequisites / Notice | Requirements: basic knowledge in Medicinal Chemistry and Pharmacology. Ability to read and understand scientific publications written in English. | |||||
535-0021-00L | Vitamins in Health and Disease | W | 1 credit | 1V | C. Müller | |
Abstract | Vitamins are essential organic compounds that cannot be synthesized by an organism and hence, thy have to be acquired from the diet. This lecture will give an overview about the application of vitamins in health and disease. | |||||
Objective | The aim of this lecture is a critical examination of the students with the topic of "Vitamins in Health and Disease". The students will get an overview of vitamins, of their medical applications and the role of the pharmacist with "over-the-counter" products. | |||||
Content | Deficiencies of particular vitamins result in specific diseases such as for example scurvy (vitamin C deficiency). Such disease patterns are usually easily recognized and facile to be treated. The clinical utility of supplementation concerns people with severe deficiencies and a risk of complications. Latent vitamin deficiencies might result in variable disorders and risks. As an example neurological disorders in elderly as a consequence of chronic lack of vitamin B12 should be mentioned. Subclinical deficiencies are often difficult to assess. However, these are exactly the cases where advice of a pharmacist is requested. A large intake of vitamins by over-supplementation or food fortification might be dangerous (hypervitaminosis). This is in particular the case for fat-soluble vitamins or in the case of constant intake of high amounts of water-soluble vitamins over a long time period. The lecture 'Vitamins in Heath and Disease' will give an overview over the history and applications of vitamins and their functions to preserve good health. The utility of vitamin supplementation during conditions of deficiencies, potential consequences of a latent deficiency as well as risks of over-supplementation will be discussed. | |||||
Lecture notes | Hand-outs will be distributed during the lecture (partly in English, partly in German). | |||||
Literature | Book recommendation: reference books: - Handbuch Nährstoffe, Burgerstein, Trias Verlag ISBN 978-3-8304-6071-8 Arzneimittel und Mikronährstoffe - Medikationsorientierte Supplementierung WVG, ISBN 978-3-8047-2779-3 | |||||
Prerequisites / Notice | Requirements: Basic knowledge in biochemistry and pharmacology. Ability to read and understand scientific publications in English. | |||||
535-0360-00L | Evidence Based Phytotherapy | W | 1 credit | 1V | J. Drewe, K. Berger Büter | |
Abstract | Based on epidemiology, economic importance and evidence-based medicine, basic principles of rational phytotherapy will be discussed: a) Identification of drug candidates, b) registration requirements, c) criteria to assess efficacy, d) biomarkers and pharmacokinetics, e) safety and f) principles of extract generation. Important prototypes will be discussed | |||||
Objective | Students should learn the importance of rational (= evidence based) pharmacotherapy with herbal extracts: They should get to know the development process of herbal drugs: o How are interesting development candidates are being identified? What are the strategies? o What are the regulatory requirements (traditional use, well-established use, new herbal entities)? o What are the selection criteria? o Assessment of efficacy (animal-/human studies, biomarker) o Pharmacokinetics o Safety (Toxicity, unwanted adverse effects, drug-drug interactions) o Pharmaceutical quality o Securing of herbal identity (collections, agriculture) o Quality management o selection of appropriate extraction procedures? Important prototy pes will be presented and critically discussed: Hypericum perforatum Rhodiola rosea Lavendelöl Pelargonium Echinacea Petasites Cimicifuga Silybum marianum Iberogast® | |||||
Content | Effektive Zeiten 14.45 - 15.30; 15.45-16.30) 19.09.2018 Qualität Arzneipflanzen-Fertigprodukte, Monographien (Kommission E, ESCOP, HMPC), Unterschiede hinsichtlich des Registrierungsstatus und -anforderungen: traditional use, well established use und new herbal entities, Methoden Produktentwicklung (Pflanzenauswahl, Anbau, Extraktentwicklung, präklinische und klinische Entwicklung) 26.09.2019 Grundlegende Begriffe der evidenzbasierten Medizin Hypericum perforatum (inklusive Pyrrolizidinalkaloid Problematik 03.10.2018 Rhodiola rosea Lavendelöl 10.10.2018 Pelargonium Echinacea 17.10.2018 Petasites (inklusive Pyrrolizidinalkaloid-Problematik) 24.10.2017 Cimicifuga Silybum marianum 31.10.2018 Iberogast® Prüfung (MC) | |||||
Lecture notes | Die Skripten werden vor den jeweiligen Vorlesungen per Email an die Teilnehmer versandt | |||||
535-0137-00L | Clinical Chemistry II | W | 1 credit | 1V | M. Hersberger | |
Abstract | Detailed knowledge on particular aspects of clinical chemistry and medical laboratory diagnostics concerning quality control, point-of-care analytics, analytics of kidney stones, tumor markers, diagnosis of HIV and hepatitis, pharmacogenetics, thyroid function, bone metabolism and laboratory diagnosis of hypertension. | |||||
Objective | Detailed knowledge on the implementation and interpretation of clinical laboratory diagnostic tests. Competence to interprete selected tests. | |||||
Content | Internal and external quality control, point-of-care analytics, analytics of kidney stones, use of tumor marker determinations, diagnosis of HIV and hepatitis, pharmacogenetics, thyroid function, bone metabolism and laboratory diagnosis of hypertension. | |||||
Lecture notes | Documentation will be available before the lectures electronically. | |||||
Literature | - Jürgen Hallbach, Klinische Chemie und Hämatologie für den Einstieg, Thieme Verlag - Harald Renz, Praktische Labordiagnostik, de Gruyter Verlag - Walter Guder, Das Laborbuch für Klinik und Praxis, Elsevier Verlag - Lothar Thomas, Labor und Diagnose, TH Books - William Marshall, Clinical Chemistry, Mosby Ltd. - Alan H.B. Wu, Tietz, Clinical Guide to Laboratory Tests, Saunders | |||||
Prerequisites / Notice | Requirement: basic knowledge in clinical chemistry and laboratory diagnostics | |||||
535-0022-00L | Computer-Assisted Drug Design | W | 1 credit | 1V | G. Schneider | |
Abstract | The lecture series provides an introduction to computer applications in medicinal chemistry. A focus is on molecular representations, property predictions, molecular similarity concepts, virtual screening techniques, and de novo drug design. All theoretical concepts and algorithms presented are illustrated by practical applications and case studies | |||||
Objective | The students will learn how computer simulation generates ideas for drug design and development, understand the theoretical principles of property prediction and computer-generated compound generation, and understand possibilities and limitations of computer-assisted drug design in pharmaceutical chemistry. As a result, they are prepared for professional assessment of computer-assisted drug design studies in medicinal chemistry projects. | |||||
Literature | Recommended textbooks: 1) G. Schneider, K.-H. Baringhaus (2008) "Molecular Design - Concepts and Applications", Wiley-VCH: Weinheim, New York. 2) H.-D. Höltje, W. Sippl, D. Rognan, G. Folkers (2008) "Molecular Modeling: Basic Principles and Applications", Wiley-VCH: Weinheim, New York. 3) G. Klebe (2009) "Wirkstoffdesign", Spektrum Akademischer Verlag: Heidelberg. | |||||
Prerequisites / Notice | Successful participation in this course is required for a research project ("Forschungspraktikum") in the CADD group. |
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