Silvia Grandoni, Nicola Cesari, Giandomenico Brogin, Paola Puccini, Paolo Magni
{"title":"Building in-house PBPK modelling tools for oral drug administration from literature information.","authors":"Silvia Grandoni, Nicola Cesari, Giandomenico Brogin, Paola Puccini, Paolo Magni","doi":"10.5599/admet.638","DOIUrl":"10.5599/admet.638","url":null,"abstract":"<p><p>The interest in using physiologically-based pharmacokinetic (PBPK) models as a support to the drug development decision making process has rapidly increased in the last years. These kind of models are examples of the \"bottom up\" modelling strategy, which progressively integrates into a mechanistic framework different information as soon as they become available along the drug development. For this reason PBPK models can be used with different aims, from the early stages of drug development up to the clinical phases. Different software tools are nowadays available. They can be categorized in \"designed software\" and \"open software\". The first ones typically include commercial platforms expressly designed to implement PBPK models, in which the model structure is pre-defined, assumptions are generally not explicitly declared and equations are hidden to the user. Even if the software is validated and routinely used in the pharmaceutical industry, sometimes they do not allow working with the flexibility needed to cope with specific applications/tasks. For this reason, some scientists prefer to define and implement their own PBPK tool in \"open\" software. This paper shows how to build an in-house PBPK tool from species-related physiological information available in the literature and a limited number of drug specific parameters generally made available by the drug development process. It also reports the results of an evaluation exercise that compares simulated plasma concentration-time profiles and related pharmacokinetic (PK) parameters (i.e., AUC, C<sub>max</sub> and T<sub>max</sub>) with literature and in-house data. This evaluation involved 25 drugs with different physico-chemical properties, intravenously or orally administrated in three different species (i.e., rat, dog and man). The comparison shows that model predictions have a good degree of accuracy, since the average fold error for all the considered PK parameters is close to 1 and only in few cases the fold error is greater than 2. In summary, the paper demonstrates that addressing specific aims when needed is possible by creation of in-house PBPK tools with satisfactory performances and it provides some suggestions how to do that.</p>","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"4-21"},"PeriodicalIF":3.4,"publicationDate":"2019-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8957249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81244719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The What's Happening to My Body? Book for Boys: A Growing-up Guide for Parents and Sons (3rd ed.). By Lynda Madaras, with Area Madaras. New York: Newmarket Press, 2000. xxii + 231 pp., illustrations, index. Paperback, ISBN 1-55704-443-0, $12.95.","authors":"D. G. Berger","doi":"10.1080/01614576.2001.11074454","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074454","url":null,"abstract":"cases where medication is effective. The final chapters address specific issues and pitfalls in dealing with couples' problems. Clearly, the authors have returned to firmer ground here and summarize well the essence of their approach. They provide valuable insights and recommendations for dealing with a wide range of clinical problems, including communication difficulties, anger and conflict, and differences in expectations. In each of these areas, the authors offer well-grounded and theoretically sound advice for therapists at all levels of experience. What does the future hold for sex therapy in the age of Viagra? Clearly, the juggernaut of medical therapies such as Viagra has prompted a serious reevaluation of the role of sex and marital therapy. Weeks and Gambescia are to be commended for providing a wellreasoned and highly readable evolution toward \"a new sex therapy.\"","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"374 - 375"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074454","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Handbook of Religion and Health. By Harold Koenig, Michael E. Mc Cullough, and David Larson. New York: Oxford University Press, 2001. vii + 112 pp., references, index. Hardback, ISBN 0-19-511866-9, $56.00.","authors":"C. Cesaretti","doi":"10.1080/01614576.2001.11074446","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074446","url":null,"abstract":"","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"59 1","pages":"364 - 365"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074446","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"When Religion is its Own Worst Enemy: How Therapists Can Help People Shed Hurtful Notions That Masquerade as Good Theology","authors":"Joan H. Timmerman","doi":"10.1080/01614576.2001.11074431","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074431","url":null,"abstract":"It is well known that religious beliefs are influential in forming the attitudes and behaviors of people regarding their sexual expression. It is less well known that a significant obstacle to sexual health and spiritual growth results from inadequate or distorted theological notions that masquerade as authentic teaching of faith communities. Three common distortions of religious belief—tenets about suffering, morality, and “God's plan”—may stand in the way of personal growth and social well being. The tests of good theology that are systematically applied by working theologians can also be understood and applied by therapists and individual seekers. This process may help remove the obstacles of low self-esteem, false guilt, and superstition that stall true spiritual growth. Religion and spirituality are not the enemies of sexual health and social well being. False or distorted interpretations of religious belief are hurtful; these can and should be unmasked and replaced.","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"259 - 266"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074431","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spirituality, Transgender Identity, and Coming Out","authors":"W. Bockting, C. Cesaretti","doi":"10.1080/01614576.2001.11074435","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074435","url":null,"abstract":"In a number of cultures (e.g., Native American and Asian communities), the transgender experience has held positive, spiritual meanings—a value often denied to transgender people in today's Western society. We posit that gender dualism (male versus female, man versus woman, masculine versus feminine) has contributed to the social stigmatization of transgenderism, and that dualism in terms of the separation between science and religion (body versus spirit) has contributed to the medicalization (and pathologization) of transgenderism. A paradigm shift has been gradually occurring over the past decade, in which transgender individuals are affirming their identity and sexuality as distinct from both male and female identity and sexuality. This process can be described as a spiritual discernment or awakening, not only for the individual involved but also for family and community, including their community of faith. Attention to this coming-out process by mental health practitioners and spiritual counselors can help transgender individuals to transform stigma into pride and to integrate body and spirit. Case vignettes taken from the first author's clinical practice illustrate the spiritual aspects of the transgender coming-out process facilitated in psychotherapy.","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"291 - 300"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074435","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Clitoral Truth: The Secret World at Your Fingertips. By Rebecca Chalker. New York: Seven Stories Press, 2000. 256 pp., illustrations, references, resources, glossary, index. Paperback, ISBN 1-58322-059-3, $19.95.","authors":"C. Cassell","doi":"10.1080/01614576.2001.11074452","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074452","url":null,"abstract":"tically but nonetheless effectively characterizing men's sexual energy as fire, quick to burst into flame and then extinguish, and women's energy as water, slow to boil but able to hold its heat. The authors provide explicit, beautifully illustrated instructions for men in bringing the waters of female passion to a gradual boil and for women in pleasurably delaying a male partner's incendiary responses. They have plenty of fun with their material, employing wit and double entendre in their descriptions of such sport as \"tongue kung-fu\" and the mechanics of \"the art of screwing.\" A big plus is the section on how to drive a woman wild manually in ways that the penis is not engineered to do. This section alone could be worth a Chinese emperor's ransom to the \"watery\" sex. The authors are on solid footing when teaching the intricacies of lovemaking and energy flow, but they stumble when turning their attention to relationships. In Chapter 6, after noting that cultivating love is a profound subject that cannot be summarized in a few paragraphs, they try to do what they have just claimed is impossible, in nine pages filled with Cliff Notes-style communication techniques and meditations. This chapter seems to bear the bold handprint of a nervous editor and consequently reads like an afterthought. Chapter 7, \"Sexing the Spirit,\" as well as parts of Chapter 5, meander into what some might call \"woowoo land.\" Although the laudable intent is to further connect body and spirit, rituals of such complexity abound that I suspect few couples not already well acquainted with Tantric or Taoist practices will be inclined to give them a thorough workout. For example, in performing the 8-step \"Orgasmic Upward Draw,\" my partner and I would be asked to, among other things, concentrate on \"smiling to our sexual organs,\" spiraling the energy in our heads by rolling our eyes in circles, and keep reminding ourselves to \"continue to make love.\" To be honest, I think I'd be happier putting my clothes on and shaking my tail-feathers at the nearest dance club. But, then, maybe that's just me. I can only absorb so much \"woo-woo\" before I roll my eyes for real. The authors also recommend \"soul-mating\" for \"soul orgasms.\" The directions are hard to track, and, I imagine, even harder to follow-a bit too much like assembling furniture bought at an Ikea sale. The concept also begs the question of whether even multiple orgasms are climactic enough. By raising the bar to \"soulgasms,\" I wonder how many readers will wind up feeling more inadequate than enlightened should they try and fail to reach these peaks. Throughout the book I noticed a paucity of attention to same-sex couples. Although the authors inclusively tip their hat to lesbians and gays, the narrative avoids specific, concrete examples. And the book is replete with lovely, graphic illustrations-mostly of young, slender, attractive, able-bodied, and impressively endowed heterosexual duos. I believe a book of this caliber owe","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"371 - 373"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074452","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Multi-Orgasmic Couple: Sexual Secrets Every Couple Should Know. By Mantak Chia, Maneewan Chia, Douglas Abrams, and Rachel Carlton Abrams. New York: HarperCollins, 2000. xvi + 204 pp., illustrations, notes, resources. Hardback, ISBN 0-06-251613-2, $24.00.","authors":"J. Davidson","doi":"10.1080/01614576.2001.11074451","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074451","url":null,"abstract":"I think he would allow that I have the right to get out of the passenger seat and tell him what I felt we did not see. First, after the historical and literary romp, it would have been very interesting to hear contemporary voices about castration besides that of Taylor. A quick check on the Internet reveals that those voices are available. Perhaps this is work for someone in the sexological field. Second, although Taylor kicks against the symbolic aspects of castration, the fact is that we live with it. Here, again, our society is examining the implications of Freud's statement that anatomy is destiny. Westerners are engaged in a serious sexual revolution and, in the process, are encountering the sexual mores and practices of other cultures. Much is being written about female and male sexual mutilation and sexual oppression. Granting that this is not Taylor's subject, he displays too keen a facility of comprehension to leave it unmentioned-or at least issue the challenge to others. Third, in a brilliant examination of Matthew 19:12, Taylor presents a literal interpretation of Jesus' positive statement about eunuchs. He does a masterful job at linking those sayings and actions of Jesus, as well as connecting him to the celibate Essene sect at Qumram. No, I will not summarize here since it would be like telling you the end of a mystery novel. However, again Taylor becomes fascinated with the analysis and in tilting with the allegorical interpretations. There are tantalizing \"what ifs,\" but no creative posits or handoffs. A bit of arrogance here, I think. Alas, I guess that finally Taylor has rubbed up against my defenses. What I am getting at is that with all his outstanding qualities, Taylor does not see beyond his own construct. It feels as if he is trapped in the magnificent birdcage he has constructed. In gaining mastery over his subject, Taylor creates a feeling of intellectual claustrophobia. What is missing in this book is the reality that neither the thinkers of old, nor the traditions they spawned, nor new ideas or \"discoveries,\" nor contemporary experiences are mute. They are in constant dialogue and potentially corrective and I or corroborative. What is missing are the signs of hope that there is growing a strategy of dialogue that makes room in the conversation for many perspectives and welcomes people in the interpretative loop who are often left out or marginalized. Taylor has placed himself boldly into this conversation, and he should be warmly welcomed. He will find the company diverse and complex. I am sure he will bring A Game of Chess or some other obscure Elizabethan play into the dialogue-even brilliantly. And others will share their divining rod with him. So, if you are looking for a book well written with ideas clearly presented, with a vocabulary that shuns the trite formulas of psycho-scholar chant, where a paragraph is a paragraph and there is nary a sentence that ends with (High, Higher & Highest, 2001) but just a period,","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"153 1","pages":"370 - 371"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074451","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Editor's Note: Encouraging Change in Deeply Held Values","authors":"S. Plaut","doi":"10.1080/01614576.2001.11074427","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074427","url":null,"abstract":"As we have announced previously in this space, this will be the last issue of this Journal, a least for the foreseeable future. When our sponsoring association made its decision to cease publication under its banner, we had already committed to making this a special issue on sexuality and religion. However, we also had a number of papers in the process of review at that time, and wanted to be able to publish those that were acceptable as well. Therefore, this is a hybrid issue, containing a number of papers and book reviews on our special topic, plus additional papers and reviews addressing other topics. For that reason, this is also an extra-large issue. Mary O'Neill, our managing editor, deserves much of the credit for making that possible. Martha Cornog and Tim Perper, our book review editors, not only put together a large array of excellent reviews, but provided commentary on relevant books that were not possible to review for this issue. It was Julian Slowinski, one of our consulting editors and current Chair of the Center for Religion and Sexuality, who suggested the topic for this issue. As excited as we were about the idea, this was in some ways the most labor-intensive of all the special issues we have done over the last 5 years. When working at the interface of two very value-laden areas, authors may have strong feelings about their viewpoints. When writing for a scholarly journal, however, it is important to express one's opinions in a reasoned way and to document previous thought and research when appropriate. We thank our authors for their cooperation and our guest editor, S. Margretta Dwyer, for her diplomacy and perseverance in effectively addressing these needs. The issue is a much stronger one for those efforts. Associate","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"251 - 251"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074427","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Sexual Ethics in College Textbooks: A Suggestion","authors":"D. Helminiak","doi":"10.1080/01614576.2001.11074439","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074439","url":null,"abstract":"This paper responds to a survey of 10 sexuality textbooks that revealed pervasive uncertainty about the nature of sexual ethics and inconsistency about the role of social scientists vis-à-vis ethics. To help bring more consistency to the textbook offerings and to argue the legitimacy of including scientifically based ethical judgments in sexuality textbooks, this paper invokes the long-standing Western tradition of natural law theory, which holds that adherence to, or violations of, the inherent requirements of healthy and wholesome collective human functioning are the essential meaning of right and wrong, good and evil. Proposing an empirically grounded tripartite model of the human (organism, psyche, and spirit), this approach clarifies the nature of human sexuality and specifies the interpersonal as the determinative consideration. The overall suggestion is that, on such a philosophical basis and in cases where research findings approach a consensus, not only can sexologists qua sexologists responsibly say what ought or ought not to be done sexually—that is, they can make ethical judgments—but also, as a matter of professional responsibility, they are ethically bound to do so and to report such judgments in the sexuality textbooks.","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"320 - 327"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074439","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Therapeutic Dilemmas: Solving Sexual Difficulties in the Context of Religion","authors":"Julian Slowinski","doi":"10.1080/01614576.2001.11074433","DOIUrl":"https://doi.org/10.1080/01614576.2001.11074433","url":null,"abstract":"Working with religious issues in therapy is essential for those clients whose belief system is the basis for their difficulty. The foundation of sexual health is frequently hindered by the attitude of traditional religious understanding and teachings about sexuality. Religious beliefs often contribute to the formation of sexual difficulties, and can also interfere with the progress of therapy. Religious belief systems can broadly be categorized as fixed, or absolute, and process, or evolving. Each has a set of core values that influence conscience and behavior. Formation of conscience becomes difficult without guidelines for decision-making. The areas of scripture, tradition, reason, and experience are explored to gain a sense of where the authority for teaching and decision-making lies. Clinical examples illustrate the importance of understanding the role of religion-induced anxiety in interfering with the sexual response cycle and contributing to sexual dysfunction in both men and women. Homosexuality is explored with a special reference to biblical themes.","PeriodicalId":83768,"journal":{"name":"Journal of sex education and therapy","volume":"26 1","pages":"272 - 280"},"PeriodicalIF":0.0,"publicationDate":"2001-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/01614576.2001.11074433","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59229807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}