A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions

Clarridge KE, Chin SJ, Stone KD. Overview of FDA drug approval and labeling. J Allergy Clin Immunol Pract. 2022;10(12):3051–6. https://doi.org/10.1016/j.jaip.2022.09.005.

Article  CAS  PubMed  Google Scholar 

Qu Y, Li T, Liu Z, Li D, Tong W. DICTrank: the largest reference list of 1318 human drugs ranked by risk of drug-induced cardiotoxicity using FDA labeling. Drug Discov Today. 2023;28(11):103770. https://doi.org/10.1016/j.drudis.2023.103770.

Article  CAS  PubMed  Google Scholar 

Lee M, Han JM, Lee J, Oh JY, Kim JS, Gwak HS, Choi KH. Comparison of pharmacogenomic information for drug approvals provided by the national regulatory agencies in Korea, Europe, Japan, and the United States. Front Pharmacol. 2023;14:1205624. https://doi.org/10.3389/fphar.2023.1205624. eCollection 2023. hsgwak@ewha.ac.kr.

Hanada K, Kaneko M, Narukawa M. Comparison of approved dosages for pediatric and adult populations based on US labeling information. Ther Innov Regul Sci. 2015;49(4):576–83.

Article  PubMed  Google Scholar 

NIH. Best Pharmaceuticals for Children Act (BPCA). https://www.nichd.nih.gov/research/supported/bpca. Visited and cited on Oct 5, 2023.

Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290(7):905–11. https://doi.org/10.1001/jama.290.7.905.

Article  PubMed  Google Scholar 

Pediatric Trials Network. PTN Studies. https://pediatrictrials.org/ptn-studies/. Visited and cited on Oct 5, 2023.

Park EJ, Wu K, Mi Z, Dong T, Lawrence JP, Ko CW, Huang SM, Zhang L, Crentsil V, Zhang J, Xu NN. A systematic comparison of cockcroft-gault and modification of diet in renal disease equations for classification of kidney dysfunction and dosage adjustment. Ann Pharmacother. 2012;46(9):1174–87. https://doi.org/10.1345/aph.1Q757.

Article  PubMed  Google Scholar 

Lemaitre F, Budde K, Van Gelder T, Bergan S, Lawson R, Noceti O, Venkataramanan R, Elens L, Moes DJAR, Hesselink DA, Pawinski T, Johnson-Davis KL, De Winter BCM, Pattanaik S, Brunet M, Masuda S, Langman LJ. Therapeutic drug monitoring and dosage adjustments of immunosuppressive drugs when combined with Nirmatrelvir/Ritonavir in patients with COVID-19. Ther Drug Monit. 2023;45(2):191–9. https://doi.org/10.1097/FTD.0000000000001014.

Article  CAS  PubMed  Google Scholar 

Krens SD, Lassche G, Jansman FGA, Desar IME, Lankheet NAG, Burger DM, van Herpen CML, van Erp NP. Dose recommendations for anticancer drugs in patients with renal or hepatic impairment. Lancet Oncol. 2019;20(4):e200–7. https://doi.org/10.1016/S1470-2045(19)30145-7.

Article  CAS  PubMed  Google Scholar 

Klump KL, Culbert KM, Slane JD, Burt SA, Sisk CL, Nigg JT. The effects of puberty on genetic risk for disordered eating: evidence for a sex difference. Psychol Med. 2012;42(3):627–37.

Article  CAS  PubMed  Google Scholar 

Fortes MRS, Zacchi LF, Nguyen LT, Raidan F, Weller MMDCA, Choo JJY, Reverter A, Rego JPA, Boe-Hansen GB, Porto-Neto LR, Lehnert SA, Cánovas A, Schulz BL, Islas-Trejo A, Medrano JF, Thomas MG, Moore SS. Pre- and post-puberty expression of genes and proteins in the uterus of Bos indicus heifers: the luteal phase effect post-puberty. Anim Genet. 2018;49(6):539–549.

Smith JR, Emerson SR, Kurti SP, Gandhi K, Harms CA. Lung volume and expiratory flow rates from pre- to post-puberty. Eur J Appl Physiol. 2015;115(8):1645–52.

Article  PubMed  Google Scholar 

Watanabe Y, Yamaguchi T, Tanaka S, Sasaki A, Naitoh T, Matsubara H, Yokote K, Okazumi S, Ugi S, Yamamoto H, Ohta M, Ishigaki Y, Kasama K, Seki Y, Tsujino M, Shirai K, Miyazaki Y, Masaki T, Nagayama D, Saiki A, Tatsuno I. Characteristics of childhood onset and post-puberty onset obesity and weight regain after laparoscopic sleeve gastrectomy in japanese subjects: a subgroup analysis of J-SMART. Obes Facts. 2022;15(4):498–507. y.watanabe1216@gmail.com

Lyons HS, Mollan SLP, Liu GT, Bowman R, Thaller M, Sinclair AJ, Mollan SP. Different characteristics of pre-pubertal and post-pubertal idiopathic intracranial hypertension: a narrative review. Neuroophthalmology. 2022;47(2):63–74.

Article  PubMed  PubMed Central  Google Scholar 

Ben-Haroush A, Goldberg-Stern H, Phillip M, de Vries L. GnRH agonist treatment in girls with precocious puberty does not compromise post-pubertal uterine size. Hum Reprod. 2007;22(3):895–900.

Article  CAS  PubMed  Google Scholar 

Chaki B, Pal S, Chattopadhyay S, Bandyopadhyay A. High-intensity exercise-induced oxidative stress in sedentary pre-pubertal & post-pubertal boys: a comparative study. Indian J Med Res. 2019;150(2):167–74.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Spjuth L, Ljungvall K, Saravia F, Lundeheim N, Magnusson U, Hultén F, Rodríguez-Martínez H. Does exposure to di(2-ethylhexyl) phthalate in pre-pubertal boars affect semen quality post-puberty? Int J Androl. 2006;29(5):534–42.

Article  CAS  PubMed  Google Scholar 

Close EL, Garcia MC, Bazett-Jones DM. Pre-pubertal runners demonstrate greater variability in running kinematics than post-pubertal runners. Gait Posture. 2023;S0966–6362(23):00136–44.

Google Scholar 

Ezzedine K, Diallo A, Léauté-Labrèze C, Seneschal J, Boniface K, Cario-André M, Prey S, Ballanger F, Boralevi F, Jouary T, Mossalayi D, Taieb A. Pre- vs. post-pubertal onset of vitiligo: multivariate analysis indicates atopic diathesis association in pre-pubertal onset vitiligo. Br J Dermatol. 2012;167(3):490–5.

Bale P. Pre- and post-adolescents’ physiological response to exercise. Br J Sports Med. 1981;15(4):246–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Spjuth L, Gil MA, Caballero I, Cuello C, Almiñana C, Martínez EA, Lundeheim N, Rodríguez-Martínez H. Pre-pubertal di(2-ethylhexyl) phthalate (DEHP) exposure of young boars did not affect sperm in vitro penetration capacity of homologous oocytes post-puberty. Arch Androl. 2007;53(3):141–7.

Camacho-Abrego I, González-Cano SI, Aguilar-Alonso P, Brambila E, la Cruz F, Flores G. Changes in nitric oxide, zinc and metallothionein levels in limbic regions at pre-pubertal and post-pubertal ages presented in an animal model of schizophrenia. J Chem Neuroanat. 2021;111:101889. gonzaloflores56@gmail.com

Topaloğlu U, Sağsöz H, Akbalik ME. Distribution of cytoskeletal proteins in the cat testis during the pre-pubertal and post-pubertal periods. Theriogenology. 2023;197:1–9. ugur.topaloglu@dicle.edu.tr

Gillen ZM, Housh TJ, Schmidt RJ, Herda TJ, De Ayala RJ, Shoemaker ME, Cramer JT. Comparisons of muscle strength, size, and voluntary activation in pre- and post-pubescent males and females. Eur J Appl Physiol. 2021;121(9):2487–97.

Article  PubMed  Google Scholar 

Sasaki G, Ishii T, Hori N, Amano N, Homma K, Sato S, Hasegawa T. Effects of pre- and post-pubertal dihydrotestosterone treatment on penile length in 5α-reductase type 2 deficiency. Endocr J. 2019;66(9):837–42.

Article  CAS  PubMed  Google Scholar 

Steinberg N, Pantanowitz M, Zeev A, Stern M, Dar G. Ultrasound Tissue Characterization (UTC) of the achilles tendon in pre- and post-pubertal dancers. J Dance Med Sci. 2020;24(2):51–8.

Article  PubMed  Google Scholar 

Saito H, Sawada T, Yaegashi T, Goto Y, Jin J, Sawai K, Hashizume T. Kisspeptin-10 stimulates the release of luteinizing hormone and testosterone in pre- and post-pubertal male goats. Anim Sci J. 2012;83(6):487–92.

Article  CAS  PubMed  Google Scholar 

Morales M, Spear LP. Differences in sensitivity to ethanol-induced conditioned taste aversions emerge after pre- or post-pubertal gonadectomy in male and female rats. Behav Brain Res. 2013;1(240):69–75.

Article  Google Scholar 

Fortes MR, Nguyen LT, Weller MM, Cánovas A, Islas-Trejo A, Porto-Neto LR, Reverter A, Lehnert SA, Boe-Hansen GB, Thomas MG, Medrano JF, Moore SS. Transcriptome analyses identify five transcription factors differentially expressed in the hypothalamus of post- versus prepubertal Brahman heifers. J Anim Sci. 2016;94(9):3693–702.

Article  CAS  PubMed  Google Scholar 

Chan RF, Copeland WE, Zhao M, Xie LY, Costello J, Aberg KA, van den Oord EJCG. A methylation study implicates the rewiring of brain neural circuits during puberty in the emergence of sex differences in depression symptoms. J Child Psychol Psychiatry. 2022;63(7):802–809. ejvandenoord@vcu.edu

Li Q, Pan X, Li N, Gong W, Chen Y, Yuan X. Identification of circular RNAs in hypothalamus of gilts during the onset of puberty. Genes (Basel). 2021;12(1):84.

Article  PubMed  Google Scholar 

Zheng F, Plati AR, Potier M, Schulman Y, Berho M, Banerjee A, Leclercq B, Zisman A, Striker LJ, Striker GE. Resistance to glomerulosclerosis in B6 mice disappears after menopause. Am J Pathol. 2003;162(4):1339–48.

Article  PubMed  PubMed Central  Google Scholar 

Xu SY, Shi P, Zhou RM. Post-menopausal oestrogen deficiency induces osteoblast apoptosis via regulating HOTAIR/miRNA-138 signalling and suppressing TIMP1 expression. J Cell Mol Med. 2021;25(10):4572–82.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Tyagi T, Alarab M, Leong Y, Lye S, Shynlova O. Local oestrogen therapy modulates extracellular matrix and immune response in the vaginal tissue of post-menopausal women with severe pelvic organ prolapse. J Cell Mol Med. 2019;23(4):2907–2919. shynlova@lunenfeld.ca

Wang CE, Wang JQ, Luo YJ. Systemic tracking of diagnostic function modules for post-menopausal osteoporosis in a differential co-expression network view. Exp Ther Med. 2018;15(3):2961–7.

CAS  PubMed  PubMed Central  Google Scholar 

Rollick NC, Lemmex DB, Ono Y, Reno CR, Hart DA, Lo IK, Thornton GM. Gene-expression changes in knee-joint tissues with aging and menopause: implications for the joint as an organ. Clin Interv Aging. 2018;1(13):365–75.

Article  Google Scholar 

Binder RL, Freedman MA, Sharma KB, Farage MA, Wang Y, Combs C, Moore D, Tiesman JP, Bascom CC, Isfort RJ, Warren R. Histological and Gene Expression Analysis of the Effects of Menopause Status and Hormone Therapy on the Vaginal Introitus and Labia Majora. J Clin Med Res. 2019;11(11):745–759. mfreedmd@knology.net

Kósa JP, Balla B, Speer G, Kiss J, Borsy A, Podani J, Takács I, Lazáry A, Nagy Z, Bácsi K, Orosz L, Lakatos P. Effect of menopause on gene expression pattern in bone tissue of nonosteoporotic women. Menopause. 2009;16(2):367–77.

Rangel-Zuñiga OA, Cruz-Teno C, Haro C, Quintana-Navarro GM, Camara-Martos F, Perez-Martinez P, Garcia-Rios A, Garaulet M, Tena-Sempere M, Lopez-Miranda J, Perez-Jimenez F, Camargo A. Differential menopause- versus aging-induced changes in oxidative stress and circadian rhythm gene markers. Mech Ageing Dev. 2017;164:41–8.

Article  PubMed  Google Scholar 

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