المؤلفون: Matthew S. Jeffers, Cheng En Xi, Raj Bapuji, Hannah Wotherspoon, Jonathan Kimmelman, Patrick Bedford, Daniel I. McIsaac, Manoj M. Lalu, Dean A. Fergusson

المصدر: BMC Medicine, Vol 22, Iss 1, Pp 1-15 (2024)

مصطلحات موضوعية: Preclinical, Animal, Cell therapy, Stem cell, Clinical trials, International Council for Harmonisation, Medicine

وصف الملف: electronic resource

Relation: https://doaj.org/toc/1741-7015

URL الوصول: https://doaj.org/article/7044491a50f94be9b8a292b7553bc30e

المؤلفون: Koko Tanaka, Maki Matsuhama, Rieko Saito, Seiko Miyazaki

المصدر: The Japanese Journal for the Histrory of Pharmacy. 2023, 58(1):26

المؤلفون: Indu Nambiar

المصدر: Perspectives in Clinical Research, Vol 9, Iss 2, Pp 103-106 (2018)

مصطلحات موضوعية: Communications, Food and Drug Administration, International Council for Harmonisation, narratives, serious adverse event, Medicine, Medicine (General), R5-920

وصف الملف: electronic resource

Relation: http://www.picronline.org/article.asp?issn=2229-3485;year=2018;volume=9;issue=2;spage=103;epage=106;aulast=Nambiar; https://doaj.org/toc/2229-3485

URL الوصول: https://doaj.org/article/0690d82e38714ae985706bf25336b88c

المؤلفون: Arun Bhatt

المصدر: Perspectives in Clinical Research, Vol 8, Iss 4, Pp 162-166 (2017)

مصطلحات موضوعية: Addendum, International Council for Harmonisation, investigator, regulatory, sponsor, Medicine, Medicine (General), R5-920

وصف الملف: electronic resource

Relation: http://www.picronline.org/article.asp?issn=2229-3485;year=2017;volume=8;issue=4;spage=162;epage=166;aulast=Bhatt; https://doaj.org/toc/2229-3485

URL الوصول: https://doaj.org/article/a85d393547034cc3af8e492267576be1

المؤلفون: Maki Matsuhama, Rieko Saito, Seiko Miyazaki

المصدر: Chemical and Pharmaceutical Bulletin. 2020, 68(11):1034

المؤلفون: Toussaint, Bruno

المصدر: Les Tribunes de la santé. 2020, 64(2), p. 87-97.

الاتاحة: https://www.cairn.info/revue-les-tribunes-de-la-sante-2020-2-page-87.htm

المؤلفون: Yukio HIYAMA, 檜山 行雄

المصدر: 日本PDA学術誌 GMPとバリデーション / PDA Journal of GMP and Validation in Japan. 2020, 22(2):15

المؤلفون: Prashant Kumar, Julie E Bines, Pim Velthof, Christopher Yallop, Ahd Hamidi, Sangeeta B. Joshi, Swathi R. Pullagurla, David B. Volkin, Alfred Luitjens, Menzo J. E. Havenga, Angelique A. C. Lemckert, Femke Hoeksema, Wilfried A.M. Bakker, Gert Gillissen

المصدر: Vaccine

مصطلحات موضوعية: Rotavirus, Malawi, HP-SEC, High Performance Size-Exclusion Chromatography, Cost-Benefit Analysis, ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, medicine.disease_cause, CDAI, Cell Density at Infection, USP, Up-Stream Processing, 0302 clinical medicine, Chlorocebus aethiops, GAVI, Global Alliance for Vaccines and Immunization, 030212 general & internal medicine, Child, Cost–benefit analysis, Manufacturing process, Vaccination, FFA, Focus Forming assay, UNICEF, United Nations Children's Fund, Dose-ranging study, COGs, Cost of Goods, Rotavirus vaccine, USD, United States Dollar, LIC, Low Income Countries, Infectious Diseases, Molecular Medicine, Stable liquid formulation, DOE, Design of Experiments, DS, Drug Substance, medicine.medical_specialty, qPCR, Quantitative Polymerase Chain Reaction, 030231 tropical medicine, DP, Drug Product, DSP, Down-Stream Processing, Vaccines, Attenuated, Article, WHO, World Health Organization, Rotavirus Infections, 03 medical and health sciences, medicine, Animals, Humans, HBGA, Histo-Blood Group Antigen, LLOQ, Lower Level Of Quantification, Dosing, Intensive care medicine, Vero Cells, IU, International Unit, General Veterinary, General Immunology and Microbiology, business.industry, Cost-of-goods modelling, Public Health, Environmental and Occupational Health, Rotavirus Vaccines, Infant, ELISA, Enzyme-Linked Immuno-Sorbent Assay, Oral rotavirus vaccine, Vaccine efficacy, FFU, Focus Forming Units in Focus Forming assay, CCID50, Cell Culture Infectious Dose 50%, Indonesia, MOI, Multiplicity of Infection, Fixed bed bioreactor, BSA, Bovine Serum Albumin, ORV, Oral Rotavirus Vaccine, business, MVS, Master Virus Seed

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0999be15ba4a50d9458f2980b5d44845
http://europepmc.org/articles/PMC8062787

المؤلفون: Fanny Caputo, C.A.W. David, R.J. Vandebriel, Matteo Santin, B. Halamoda-Kenzaoui, A. Howarth, Sven Even F. Borgos, S. Bremer-Hoffmann, Marco Siccardi, Neill J. Liptrott

المصدر: Journal of Controlled Release
JOURNAL OF CONTROLLED RELEASE

مصطلحات موضوعية: Test strategy, Computer science, media_common.quotation_subject, Regulatory needs, CEN, European Committee for Standardisation, ADME, Absorption, Distribution, Metabolism, Excretion, ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Pharmaceutical Science, Nanotechnology, Information needs, 02 engineering and technology, Review Article, EUNCL, European Nanomedicine Characterisation Laboratory, Gap analysis, PCC, Physicochemical characterisation, PK, Pharmacokinetic, 03 medical and health sciences, CARPA, Complement Activation related Pseudo-allergy, Quality (business), Product (category theory), API, Active Pharmaceutical Ingredient, Adaptation (computer science), NPs, Nanoparticles, 030304 developmental biology, media_common, 0303 health sciences, Ph. Eur., European Pharmacopoeia, PBPK, Physiologically based pharmacokinetic, Nanomedicine, nanotechnology-based products, regulatory needs, methodological gaps, method standardisation, method development, physicochemical characterisation, immunotoxicity assessment, Method development, Health technology, Reference Standards, 021001 nanoscience & nanotechnology, FDA, Food and Drug Administration, NCI-NCL, Nanotechnology Characterisation Laboratory, 3. Good health, Method standardisation, Identification (information), Nanotechnology-based products, Nanomedicine, Physicochemical characterisation, EMA, European Medicines Agency, ISO, International Standardisation Organisation, Immunotoxicity assessment, 0210 nano-technology, Methodological gaps

وصف الملف: application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6d510d95f65445d66e16858a26737d94
http://europepmc.org/articles/PMC8390938

المؤلفون: Mary Chadza, Gift Chareka, Aruna Bhoola, Jasmin Sukdao, Melanie Maclachlan, Kudzai Hlahla, Jayajothi Moodley, Rebecca Sakwa, Nivriti Hurbans, Mtn, Jeeva Moodley, Cindy Jacobson, Aspire Study Team, Anushka Naidoo, Bhavna Maharaj

المصدر: Contemporary Clinical Trials Communications, Vol 24, Iss, Pp 100859-(2021)
Contemporary Clinical Trials Communications

مصطلحات موضوعية: Medicine (General), PTID, Participant Identification, Dapivirine, GCP, Good Clinical Practice, Pharmacy, Audit, Article, Quality checks, SOPs, Standard Operating Procedures, R5-920, Dispensing errors, medicine, Double check, Investigational product, Pharmacology, business.industry, Investigational New Drug, General Medicine, ICH, International Council for Harmonisation, medicine.disease, Vaginal ring, Clinical trial, IP, Investigational Product, Clinical research, Medical emergency, business, NCR, No-carbon required

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d99d8ec9473d0b4f7d125147a6c1081f
http://www.sciencedirect.com/science/article/pii/S2451865421001599

المؤلفون: Tomomi Hata, Nozomu Fuse, Haruko Yamamoto, Shimon Tashiro, Jun Sakurai, Michihiko Wada, Yoichi Yamamoto, Hitoshi Ozawa, Nobuko Ushirozawa, Hideki Hanaoka, Tatsuya Maruyama, Shinobu Shimizu, Koji Todaka, Taro Shibata, Norihiro Sato, Natsuko Okita, Koji Ikeda, Kenichi Nakamura, Hiroi Kasai

المصدر: Therapeutic Innovation & Regulatory Science

مصطلحات موضوعية: education, Proportionality (law), Stakeholder engagement, Pharmacy, Clinical trial regulation, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Japan, Informed consent, Political science, Surveys and Questionnaires, media_common.cataloged_instance, Humans, Pharmacology (medical), European Union, European union, Good Clinical Practice, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), media_common, Original Research, Medical education, Informed Consent, Scope (project management), business.industry, Public Health, Environmental and Occupational Health, humanities, Research Personnel, United States, Real-world data, Clinical trial, Remote monitoring, Good clinical practice, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31d6bea12c30211963c6d27f2bef884f
https://pubmed.ncbi.nlm.nih.gov/34787814

المؤلفون: Pauline Lory, Jeffrey Lombardi, Clémence Lacroix, Paola Sanchez-Pena, Serena Romani, Aurélie Grandvuillemin

المصدر: Therapie

مصطلحات موضوعية: SOC, system organ classes, ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, SARS-CoV-2, severe acute respiratory syndrome coronavirus 2, SD, standard deviations, WHO, World Health Organization, Pharmacovigilance, MedDRA, Medical Dictionary for Regulatory Activities, SOCm, modified organ classes, MA, marketing authorisation, Humans, ANSM, French Health Agency, Pharmacology (medical), Pandemics, RPVC, French regional pharmacovigilance centres, COVID-19, coronavirus disease 2019, ADRs, adverse drug reactions, SARS-CoV-2, MERS-CoV, Middle East respiratory syndrome coronavirus, HCQ, hydroxychloroquine, Adverse reaction, COVID-19 Drug Treatment, HIV, human immunodeficiency virus, Long QT Syndrome, CT, clinical trial, RNA, Viral, MSSO, Maintenance and Support Services Organization, HEADING: Pharmacovigilance, PT, preferred term, Hydroxychloroquine

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e8c810c85ded560d30007efa0ff1080
https://pubmed.ncbi.nlm.nih.gov/35568573

المؤلفون: Aki Fujisaka, Osamu Fueki, Hiroshi Onodera, Takahiro Nakazawa, Kazuto Watanabe, Kiyoshi Kinoshita, Yoko Hirabayashi, Kosuke Ito, Kazushige Maki, Satoshi Obika, Misaki Naota, Mutsumi Suzuki, Teruyo Arato

المصدر: Nucleic Acid Therapeutics

مصطلحات موضوعية: 0301 basic medicine, medicine.medical_specialty, nonclinical safety assessments, ICH S6, health care facilities, manpower, and services, education, Drug Evaluation, Preclinical, Oligonucleotides, Guidelines as Topic, Biochemistry, 03 medical and health sciences, 0302 clinical medicine, Human use, Japan, health services administration, Drug Discovery, Genetics, medicine, Humans, Molecular Biology, health care economics and organizations, Issues in Development, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Biological Products, business.industry, Nonclinical safety, biopharmaceuticals, Product characteristics, 030104 developmental biology, 030220 oncology & carcinogenesis, Family medicine, Molecular Medicine, business, geographic locations

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bcd01f15555dd204ca64bfdf8d1d47b5
https://pubmed.ncbi.nlm.nih.gov/33470890

المؤلفون: Richard A. Kerr, David A. Keire, Hongping Ye

المصدر: mAbs

مصطلحات موضوعية: international council for Harmonisation, Ion-mobility spectrometry, hydrogen-deuterium exchange-mass spectrometry, Immunology, Hydrogen Deuterium Exchange-Mass Spectrometry, Shelf life, Mass spectrometry, thermal stability, 03 medical and health sciences, 0302 clinical medicine, Report, Immunology and Allergy, skin and connective tissue diseases, collision induced unfolding, 030304 developmental biology, intact mass, degradation, 0303 health sciences, Chromatography, Chemistry, Antibodies, Monoclonal, NISTmAb, Trastuzumab, Bevacizumab, Stability conditions, 030220 oncology & carcinogenesis, ion mobility-mass spectrometry, Monoclonal antibodies, sense organs, Rituximab, Higher Order Structure

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::17e7b04ef17e16d4502dcc7b85216aa1
https://pubmed.ncbi.nlm.nih.gov/30913973

المؤلفون: Štefančič, Matevž

المساهمون: Pompe, Matevž

مصطلحات موضوعية: High Performance Liquid Chromatography (HPLC) kromatografija, International Council of Harmonisation (ICH), Validacija metode, Fitokanabinoidi, High Performance Liquid Chromatography (HPLC) kromatografija Chromatography, Method validation, Phytocannabinoids

وصف الملف: application/pdf

Relation: https://repozitorij.uni-lj.si/IzpisGradiva.php?id=116799; https://repozitorij.uni-lj.si/Dokument.php?id=130487&dn=; https://plus.si.cobiss.net/opac7/bib/19588099?lang=sl

الاتاحة: https://repozitorij.uni-lj.si/IzpisGradiva.php?id=116799
https://repozitorij.uni-lj.si/Dokument.php?id=130487&dn=
https://plus.si.cobiss.net/opac7/bib/19588099?lang=sl

المؤلفون: MINAL R. GHANTE, NATASHA AKHADE, PREETI GOTA, ATUL NIKAM, SUPRIYA JAGTAP, VANDANA NIKAM

المصدر: Asian Journal of Pharmaceutical and Clinical Research; Vol 12 Issue 4 April 2019; 347-350 ; 2455-3891 ; 0974-2441

مصطلحات موضوعية: Method development high-performance thin-layer chromatography, Nebivolol hydrochloride, Cilnidipine, International Council for Harmonisation

وصف الملف: application/pdf

Relation: https://journals.innovareacademics.in/index.php/ajpcr/article/view/30569/19820; https://journals.innovareacademics.in/index.php/ajpcr/article/view/30569

الاتاحة: https://journals.innovareacademics.in/index.php/ajpcr/article/view/30569

المؤلفون: Tejaswini Jadhav*

مصطلحات موضوعية: Drug Excipients, Incompatibility, Spectrophotometric, Calorimetric, Isothermal, Formulation, Microscopic, Pharma Industry, Pharmaceutical, IST: Isothermal Stress Testing, DSC: Differential Scanning Calorimetry, XRD: X-ray Diffraction, NMR: Nuclear Magnetic Resonance, HPLC: High Performance Liquid Chromatography, IPEC: International Pharmaceutical Excipients Council, API: Active Pharmaceutical Ingredient, IND: Investigational New Drug, DECS: Drug Excipient Compatibility Studies, US-FDA: United States-Food and Drug Administration, ICH: International Council on Harmonisation, HSM: Hot Stage Microscopy

وصف الملف: application/pdf

Relation: http://medcraveonline.com/JAPLR/JAPLR-03-00088.pdf

الاتاحة: http://medcraveonline.com/JAPLR/JAPLR-03-00088.pdf

المؤلفون: 白茹穗, Pai, Ju-Sui

المساهمون: 施文真

مصطلحات موضوعية: 技術性貿易障礙協定, 國際標準, 國際標準組織, 國際醫藥法規協合組織, 國際醫藥法規協和會議, TBT agreement, International standard, International standardization organization, The International Council for Harmonisation, International Conference on Harmonisation, scipo, droit

Relation: http://nccur.lib.nccu.edu.tw/bitstream/140.119/119871/1/104401.pdf; http://nccur.lib.nccu.edu.tw//handle/140.119/119871

الاتاحة: http://nccur.lib.nccu.edu.tw/bitstream/140.119/119871/1/104401.pdf
http://nccur.lib.nccu.edu.tw//handle/140.119/119871