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Individu- curriculum: Physical Chemistry of Biological al needs can be interwoven into the required Macromolecules cheap atomoxetine 18mg line, Proteins & Nucleic Acids cheap 40 mg atomoxetine amex, curriculum order atomoxetine 10 mg with visa. Optimal background includes Methods in Molecular Biophysics buy generic atomoxetine 25 mg on-line, Comput- general chemistry, organic chemistry, physi- er Modeling of Biological Macromolecules, cal chemistry, two semesters of college-level and Organic Mechanisms in Biology. These physics, biochemistry or molecular biology, courses provide a conceptual framework for and calculus or a high-level math course. Students who have never by a training grant from the National Institutes taken courses in these areas are welcome, of Health. However, this support is limited to but not required, to take such courses dur- U. Tutorials and self-directed International applicants will be required to study provide alternative avenues for prepar- demonstrate fnancial support for their stud- ing for this evaluation. By sum- A list of the members of the staff and their mer of the frst year, a student will have joined research interests may be found in the a research group and embarked on thesis departmental statement on page 141. Beginning in the ffth semester, students meet annually with a faculty thesis review The department will admit well-qualifed stu- committee. Applicants Dissertation should have thorough training in general Completion of an original Investigation and biology, chemistry and physics, or to remove presentation of a dissertation are required. Degree How to Apply Requirements established by the Department Students must complete applications online of Cell Biology and the Doctor of Philosophy (www. Board, usually at the end of the second year The deadline for receipt of complete applica- of residence. Write a dissertation, embodying fndings will be invited to a Visiting Weekend to meet worthy of publication, and certifed to be a with faculty on both campuses, talk with stu- signifcant contribution to knowledge by at dents, and have a look around Baltimore. Program in Molecular Biophysics graduate students are supported for the frst two years 4. Present a fnal departmental oral exami- by a training grant from the National Institutes nation/seminar in the feld of the disserta- of Health. However, this support is limited to tion research certifed by from three to fve U. The department or program committee demonstrate fnancial support for their stud- must certify in writing that all departmental or ies and will be required to deposit funds cov- committee requirements have been fulflled. Core Courses If the funds are not deposited in a timely man- Students will generally fulfll the course ner, any offer of admission to the Program in requirements of the interdepartmental pro- Molecular Biophysics will be null and void. Members of the department who At their discretion, faculty members reserve work in the area of cell biology participate in the right to require students to take elective the joint program in Biochemistry, Cellular courses. Students are required to take understanding, diagnosis, treatment and four elective courses to further broaden their prevention of human diseases. Elective training in scientifc research and develop a courses may include courses at the School thorough knowledge of human biology and of Public Health and Homewood Campus. Elective course topics include bioorganic This program grew out of a need for gradu- chemistry, biophysical chemistry, human ate training at the interface between medicine anatomy, immunology, pathobiology, phar- and the traditional basic science disciplines. These laboratory rotations will be make discoveries in the laboratory that can approximately ten weeks long. At the end of be applied expeditiously to the diagnosis, the frst year, students will select a research treatment, and prevention of disease. New advisor from one of three rotation laborato- technology allows scientists to identify genet- ries and begin original research leading to ic and molecular defects causing or predis- their doctoral dissertation. The trainees in this pro- A University mandated Doctor of Philosophy gram are working precisely at this interface Board Oral examination must be completed by between science and medicine to contribute the end of the second year of study. Annual Students will work in well equipped labora- meetings are held until such time as the the- tories of approximately 125 program faculty sis committee believes the student is ready to located throughout the medical school cam- write their doctoral dissertation. These researchers are supported by tion is based on the student’s novel research; many shared facilities including microscopy, a public seminar of thesis work is a graduation molecular biology and protein chemistry. Requirements for Admission Financial Aid Applicants should have a bachelor degree with The program is supported by a combination undergraduate training in biology, inorganic of monies from the Lucille P. Cell biology and/or biochemistry are student is provided a stipend, health and recommended. The program covers admissions should be referred to the Offce of these benefts during the students’ frst year; the Graduate Program in Cellular and Molecu- in subsequent years the research advisor is lar Medicine, 1830 E. Complete a minimum of four years of reg- The work of this program extends over all istration as a full time, resident graduate stu- phases and dimensions of the development of dent. Demonstrate evidence of achievement and conceptual, cultural, and social problems. Write a dissertation, embodying fndings of medicine, science, and related felds of his- worthy of publication, and certifed to be a tory. Departmental offerings are particularly signifcant contribution to knowledge by at strong in the history of medicine and science least two referees from within the department for early modern Europe; medicine, science and two referees from outside. Present a fnal departmental seminar in the 20th centuries; history of disease and public feld of the dissertation research. For further information, Human Anatomy, Organ Histology, Evolution- see our website at: http://www. Students must also take at least four elective Program, School of Medicine, The Johns Hop- courses, to be determined through consul- kins University, 1830 E.

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The therapist must not collude with the patient who is in denial concerning the threat to his life discount atomoxetine 10 mg otc. The person attacks him/herself instead of looking at different ways of directly changing the situation buy cheap atomoxetine 10 mg, trying to distract him/herself discount 18 mg atomoxetine overnight delivery, avoiding or resigning him/herself to difficulties buy atomoxetine 25mg cheap, seeking comfort from others, avoiding being preoccupied with the problem, showing annoyance with those causing the difficulty, or engaging in self-comforting thoughts. Passivity and problem avoidance, with associated lowering of self esteem, may be helped by intensive aimed at improving problem solving ability. Legally, suicide means 1472 that a person ‘acting alone’ did the act that led to death and the act was done in order to cause death, and intent at the time of the act must be shown beyond reasonable doubt. Long term follow up shows that psychiatric patients kill themselves much more often than those who do not have such a history. It is important to elicit whether suicidal thoughts are present or absent and if present if they are active (e. The Catholic Church now allows full funeral rites and a Christian burial for suicides. When reading this list one cannot escape the conclusion that one is reading a potted history of the rapid social changes that characterised the latter part of the twentieth century. This is suggested by increasing suicide rates in 1474 Russia where social and economic disintegration are important, as may gun ownership in some areas. However, according to the National Parasuicide Registry,(Allen, 2005) in 2001 the percentages of male and female 1475 suicides employing drowning or hanging were not dissimilar (see Hawton ea, 2008 ), and the figures for overdoses among parasuicides for 2002 did not support large differences between the sexes. Additionally, Värnik ea (2008) examined suicide methods in Europe and hanging was the most common method among males (except in Switzerland where firearms was more common) and, in eight countries only (including Ireland) among females; firearms was the second most frequent method in five countries but it was the least common method in Scotland; and women were more likely to drown themselves than were men (except in Luxembourg). European female suicide methods (Värnik ea, 2008) Hanging – most common method in 8 countries Poisoning with drugs - most common method in 5 countries Jumping from a height - most common method in 3 countries According to Brendel ea (2008, p. This was associated with an increase in hanging and poisoning with vehicle exhaust gas. The author suggested that psychosocial factors played a role in this worrying trend. In fact, self-burning is commonest in schizophrenic patients and in 1479 Asian women. Tobacco growers in parts of Brazil (which has a relatively low reported suicide rate: Mello-Santos ea, 2006) often employ organophosphate pesticides to commit suicide whereas in Sri Lanka oleander seeds are often used for the same purpose. Sartorius (2001) points out that ingestion of phosphor- based insecticides comprise the main method employed by young Chinese women to kill themselves. Eddleston and Phillips (2004) and Li ea (2008) call for efforts to reduce the availability of such highly lethal poisons. Economic crisis (Gunnell ea, 2009) can have serious mental health consequences and the suicidogenic potential of job loss is not confined to those with a mental disorder. It is important that social welfare supports are sufficient to help people to weather the worst aspects of economic downturns and that society responds supportively to those who lose jobs or are financially compromised. Genetic/familial transmission of suicidal behaviour appears to be independent of psychiatric disorder transmission. The list of risk factors is potentially legion and individual cases will vary in the importance of each factor. Newer drugs might be given to people at risk of overdosing, but older drugs might be given to the severely depressed. One reason for the finding of increased suicidal behaviour in the first weeks after prescribing an antidepressant may be the lack of an immediate lifting of mood. Problem-solving abilities, tolerance levels for stress, life events, locus of control, and other factors must interact to push someone to suicide, whether or not they are depressed. Preventive factors (stigma, fear of death/suicide, cultural/moral/religious issues, family/child responsibilities, pregnancy, support network, survival/coping skills [e. However, Harriss ea (2005) found high suicide intent scores to correlate with ‘an absence of alcohol misuse’ in males! Clinical correlates were depression in 70%, diagnosis of cancer within 6 months of death (80%), physician visit within 1 month of death (60%), and being foreign-born (70%). Puerperium (associated with psychiatric illness; less common that previously – in fact the rate may have fallen below general population! According to Frater (2008) the self-inflicted death rate in English prisons rose to14. Prison suicides in England & Wales April 2002-March 2003 totalled 105 with 92 males and 13 females. Suicide risk is increased among civilians exposed to ‘friendly’ bombardment (Beevor, 2009, p. Jews who realised their role in organising fellow Jews for ‘resettlement’, civilians in France in 1940, (Vinen, 2006, p. However, the rate also fell during both world wars in non-belligerent countries like Switzerland.

Thalidomide had been associated with priate intervals for medical affairs activities during the birth of thousands of malformed babies in the corresponding phases of product develop- Western Europe order atomoxetine 18 mg amex. The reader can easily access local examples of current cheap 25mg atomoxetine amex, approved labeling; these will not be reproduced here cheap atomoxetine 10mg visa, and could purchase 40mg atomoxetine free shipping, in any case, rapidly As can be seen, the structure of a Japanese drug become out of date. Much of the content of drug label is a standard format that would also be famil- labeling is the subject of other chapters in this iar to physicians in Europe or North America. The Ministry of Health and Welfare has a subor- The Warnings and Contraindications sections of dinate organization known as the Pharmaceutical the drug label (items 6 and 7 in Table 31. Lastly, contra- Unlike any other jurisdiction in the world, initial indications for co-administered drugs must be promotional materials have to be specifically ap- printed as a table within a red box. Typically, drug labels are agreed usually in response to corresponding product with- with pharmaceutical companies at meetings shortly drawals under the orthodox regulations (e. Spanish translations of drug labels are permitted (especially for products sold in Cali- While all such enforcement actions may be fornia, Florida, New York, and Puerto Rico), and appealed in the Federal Court, it is usually only some mandatory, equivalent Spanish vocabulary the last of these, forced product withdrawal, that appears in the regulations (e. Usually, after 3 or 4 years of being promoted for indications, dose sizes, or market experience, annual reports can then be routes of administration that are outside the ap- made. Almost all entry- ever, there is a sentiment widely expressed in level medical affairs positions can provide this if Europe that the long and technical labels promul- the post-holder expresses appropriate interest. When making ical department, and between the company and the judgments about how to amend labeling and what regulatory authority on subjective, interpretative may or may not be an acceptable precis when grounds. As a result, most scientists (and as The goal of the meeting usually determines the type medicine is now a science, physicians are included) of meeting, moderators and speakers, and the audi- working in the industry are encouraged to partici- ence. In addition, many firms will Once the goal or goals of the meeting are deter- organize satellite meetings around a major confer- mined and agreed, then the type of conference or ence, often a half-day or evening meeting. To promote new treatment To exchange scientific information Most scientists, including physicians, have never To educate been trained to organize, let alone achieve, publi- cation of scientific meetings, conferences, or sem- inars. While Special meeting to introduce new drug hands-on experience is the best tutor, this chapter Regulatory presentations Therapeutic review conferences is aimed at helping the initial effort and also giving Special subjects, e. In Europe and Japan, it is very im- Chairman of scientific program portant to select and match the chairs of the ses- Chairman of social activities sions and the speakers by their professional and/or Collaborators and members of advisory board, some specialty vs. A large-scale conference involving section Audience chairs, speakers and other participants (not includ- ing the audience) of 100 or more requires approxi- mately 1 year to plan and organize properly. For After the decision is made regarding the goals of these large conferences, staff and/or volunteer sup- the meeting, the next action is to select a chairper- port is a necessity. Early on one needs to ing and should have a general overview responsi- secure an up-to-date mailing list to reach the pro- bility for the scientific as well as the social program. If the meeting will have a large number of partici- If one must be compiled, be sure to leave adequate pants and the staff/volunteer support appears to be time for this task and regularly update it. It is sur- inadequate, hiring a professional meeting/event prising how many scientific people frequently move planner may be the proper direction to take. In selecting a location for terials, manage the registration, and organize social the meeting, one needs to be attentive to where the and companion events, amongst the many meeting prospective participants are concentrated. If a meeting planner is selected meeting is to be fairly short in duration (3 days or who is familiar with the location of the meeting, he/ less), the objective for the meeting may require that she can offer invaluable insight into activities, fa- the meeting be located in the area of the most cilities, and site selection in that area. This is the person who will determine attending a meeting that combines sightseeing the subjects for the meeting, lay out the program, and line up the speakers. Decide on sequential or concomitant sessions The program chairman usually circulates the Divide into logical subsections draft of a program to either the conference organ- Decide on styleÐinteractive or classroom type izers or the Scientific Program Advisory Board, if How much time to be spent on science vs. It is also often very important to secure Direct mail/invitation Proceedings/publications/ supplements appropriate balanced participation of different Program and documentation Conclusions/bulletins functions or countries. For larger meetings, 3±5 years obtained and to discuss menus, audiovisual re- advance facility selection may be required to lock quirements, and general meeting layout with the in favorable rates. It may be more or handouts for registration, as well as making sure less elaborate, depending on the scope and object- that the registration table at the meeting will be ive for the meeting. This will pinpoint the registration charge for with all speakers need to be checked as to special each participant and will allow the calculation of needs, audiovisual requirements, hotel reserva- the total cost of the meeting in order to get ap- tions, and transportation, and also to mail out the proval from the firm or sponsoring organization. Depending on the type and the underwritten, by registration fees, sponsorship or a purpose of the conference, one can opt for a simple combination of both. A determination of the summary with key conclusions to be circulated to timing and pattern of spending must be made, as all the participants and company managers, or one well as a calculation of when money will be released can arrange for a full transcript, with the possibility and acquired. During the meeting, staff In conclusion, helping to organize a scientific should be available to deal with equipment failure meeting is a time-consuming and a tough job and booking problems, man the telephone desk, requiring patience and an ability to take timely and be ready to assist both speaker and audience. In order to ensure con- or removal of products no longer considered to be tinued patient protection,it is therefore necessary safe,as a result of pharmacovigilance by com- to monitor the safety profile of marketed drugs panies and regulatory agencies. Physicians benefit continuously for new signals of concern that might by being able to prescribe the most appropriate prompt revisions in prescribing information. Type B reactions are un- listed in the local prescribing information,in an predictable idiosyncratic reactions which are usu- effort to inform patients and prescribers of any ally infrequent but can be very serious or fatal.

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Monitoring permits an studies may need to be visited more frequently buy atomoxetine 10mg on-line, in-process assessment of the quality of the data depending on the accrual rate of subjects discount 40 mg atomoxetine overnight delivery, the being collected buy atomoxetine 10 mg with visa. Monitors Following a monitoring visit buy generic atomoxetine 18mg line, the monitor will ensure that the study is conducted, recorded and prepare a monitoring report for sponsor records reported in accordance with the protocol. The monitor reconciles investigational Local affiliate name Expiry date product shipped, dispensed and returned; arranges for shipment of investigational product to core country or investigative sites; checks investiga- supplies are being kept under the required storage tional product supplies at site against enrollment conditions. Failure to do so can result product inventory problems; implements tracking in some of the data having to be discarded during system for investigational product management on statistical analysis. This issue can prove to be prob- a study and project level; arranges for the return lematic when a single site is studying patients at and/or destruction of unused investigational prod- different locations. Finally, the double-blind code uct supplies; and ensures final reconciliation of must not be broken, except when essential for the investigational product supplies. Drug packaging should follow as consistent a Management of safety is a principal responsibil- format as possible within a project and must be ity of the sponsor monitor. Regulatory docu- sponsibility for informing the investigator about ments required for investigational drug use in the the safety requirements of the study. Drug supplies should be rec- changes from baseline with expected pharmaco- onciled and the integrity of the double-blind logical effects, acute and chronic effects and mul- treatment codes should be confirmed. In multicenter about the event to headquarters within 24 h and trials, a single lead investigator may sign a pooled headquarters will get the information to the drug study report. Presents the detailed efficacy the annual report must be written in a clear, concise findings, including the intent-to-treat analysis manner that accurately summarizes and interprets population and the efficacy data listings. Presents the detailed safety find- vide clear, simple graphs, tables, and figures to ings, including the intent-to-treat analysis illustrate and support safety findings. What is needed to get a drug Fourth, the chapters on Phase I clinical trials and approved is not the same as what is needed to make pharmacoeconomic research have been written by that drug into a commercial success. The typical pharmaceutical velopment, how this is done, and what preclinical physician has usually paid little attention to these information is needed in order to carry it out. Pharmaceutical physicians, spe- view regulatory affairs as the implementation of cialized though they may be in one discipline or their clinical development plans (and probably another, are well-advised to keep an observant eye vice versa), the proper constraints imposed by regu- on the interactions between their own and other latory authorities are so fundamental that they de- company departments. From the cellular stage, the re- searcher next defines specific molecular targets, An outline of the thought processes involved in such as receptors or cellular enzymes that comprise designing and implementing a Drug Discovery pro- the destructive phenotype. This chapter Researchers will target systems which are will discuss the process, and give practical examples affected by, or may be directly involved with, a from contemporary drug discovery scenarios. The treatments arising from All drug discovery projects depend on luck to these types of approaches can be palliative, or be successful, but research and careful planning can may find a market or need as disease-modifying improve chances of success and lower the cost. Prime examples of palliative therapies are Project teams can streamline the discovery process drugs designed to alleviate side effects of treatment by mapping the most direct methods that will yield with toxic chemotherapeutic drugs, such as nausea a discovery. In these cases, drug discovery scien- biology, chemistry, robotics, and computer simula- tists search for drugs which alleviate each symptom tions, years can be eliminated from the search for as if it were an isolated pathology. The costs of getting a new therapeutic Disease-modifying drugs are those which directly into the marketplace in 1997 were estimated at affect the primary disease. In many cases, prelimin- from a particular receptor in normal cells, but are ary research has been published on several aspects mutated, and thus are constitutively active or con- of the pathology. Is there an anomaly in a cell derived from a ations in the cellular architecture required for tumor, to use a cancer example, which renders that mitosis (cytoskeleton and cell motility). Unless a company can work faster or Hypothetically, because we also know that ster- better than the competition by taking a direct ap- oids, a currently used therapeutic, works by inhib- proach, it is, perhaps, a better strategy to approach ition of gene expression of many of these mediators, the target identification issue less directly. Are the transcription mechanisms known, seek to inhibit transcription factor activation by and if so, are there any other required enzymes or phosphorylation or proteolysis, while another proteins which are regulated by those same mech- group seeks to inhibit the binding of the transcrip- anisms? The real work comes in families with patterns of hereditary disease, and sequencing and identifying these genes, and ascer- mapping the transmission of the disease to find taining which are the unknown, novel sequences. The are then used in functional assays to prevent a Human Genome Project is a consortium of govern- response thought to be critical for disease develop- ment and industry-funded laboratories, which se- ment. Genomics and New Target Identification At the time of writing complete genomic se- quences are available for atleast 141 viruses, 51 Drug companies have recently become involved in organelles, two eubacteria, one eukaryote and the use of genomics to identify new genes which most mammalian mitochondria. Mo- for which complete genome data are available in- lecular biologists can seek mutations or alterations clude Haemophilus influenzae, Mycoplasma geneta- in genetic signatures which are predictive of the lium, and Saccharomyces cervisiae. The access to gene pharmacologists often study isolated arteries, sequence information should shave months off of which are maintained in a physiological salt solu- the discovery process, allowing rapid cloning of tion. That task is assigned to the cell biologists, lecular screening, they are now relegated to who will have to study basic cellular mechanisms secondary or tertiary roles as validation of the with normal and diseased genes, or study trans- targets or drugs discovered. Drug discovery scientists must bear in mind what In the pharmaceutical industry, as in basic re- the broader effects of inhibiting, modifying, or search, the cause of a disease can be identified by eliminating this new target would be on the organ- introducing a suspect gene into the genome of a ism. The choice of a target for Embryos are removed at the 4 ±8 cell-stage, micro- a disease will be critical to the outcome and per- injected or transfected with a plasmid containing the formance of the drug, and will determine what gene to be expressed, probably engineered to be organs or tissues will be susceptible to side effects. However, in most cases, homozygous knockout These veterinary professionals and committees mice (mice which lack the gene in both sets of oversee the issues related to humane use, as well as chromosomes) develop abnormalities that are in- updating researchers on more efficient methods compatible with life beyond an early embryonic which might allow reduction in the number of stage. Until reliable computer models accurately predict the effect of Spontaneously Arising Phenotypic Models each chemical compound on the cell, the tissue and the organism as a whole, physiological studies Mutations which cause disease can arise spontan- will remain critical.