Works matching DE "INTERNATIONAL Conference on Harmonisation"

Results: 43

Development and Validation of a New LC-MS/MS Method for Simultaneous Quantification of Ivacaftor, Tezacaftor and Elexacaftor Plasma Levels in Pediatric Cystic Fibrosis Patients.

Published in:

Pharmaceuticals (14248247), 2025, v. 18, n. 7, p. 1028, doi. 10.3390/ph18071028

By:

Mancini, Alessandro;
Simeoli, Raffaele;
Cristiani, Luca;
Cairoli, Sara;
Ciciriello, Fabiana;
Boni, Alessandra;
Alghisi, Federico;
Rossi, Chiara;
Antonetti, Giacomo;
Vici, Carlo Dionisi;
Fiocchi, Alessandro Giovanni;
Cutrera, Renato;
Goffredo, Bianca Maria

Publication type:

Article

Understanding the chemical stability of peptidomimetic therapeutics using high-resolution mass spectrometry: a study of terlipressin and its degradation products.

Published in:

Analytical & Bioanalytical Chemistry, 2025, v. 417, n. 19, p. 4311, doi. 10.1007/s00216-025-05944-7

By:

Chawathe, Ashwini;
Sharma, Nitish

Publication type:

Article

DEVELOPMENT AND VALIDATION OF A NEW UHPLC-DAD APPROACH FOR ATOMOXETINE DETECTION IN SEVERAL MEDICINAL PLANTS.

Published in:

Journal of Faculty of Pharmacy of Ankara University / Ankara Üniversitesi Eczacilik Fakültesi Dergisi, 2024, v. 48, n. 1, p. 189, doi. 10.33483/jfpau.1345130

By:

CEYLAN, Burhan

Publication type:

Article

Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes.

Published in:

Diabetes, Obesity & Metabolism, 2012, v. 14, n. 9, p. 859, doi. 10.1111/j.1463-1326.2012.01627.x

By:

Heise, T.;
Hermanski, L.;
Nosek, L.;
Feldman, A.;
Rasmussen, S.;
Haahr, H.

Publication type:

Article

Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Ketoprofen and Thiocolchicoside in combined Solid Oral Dosage Form.

Published in:

International Journal of Pharmacy & Life Sciences, 2016, v. 7, n. 4, p. 4979

By:

Joshi, Toral;
Bhavsar, Ankita;
Senta, Arvind

Publication type:

Article

Stability indicating RP-HPLC method for estimation of bamifylline hydrochloride in tablet formulation: Development and validation consideration.

Published in:

Thai Journal of Pharmaceutical Sciences, 2014, v. 38, n. 4, p. 168

By:

Patel, Rashmin. B.;
Patel, Mrunali. R.;
Goswami, Tapan S.

Publication type:

Article

The comparative verification of calibration curve and background fundamental parameter methods for impurity analysis in drug materials.

Published in:

XRS: X-ray Spectrometry, 2017, v. 46, n. 5, p. 382, doi. 10.1002/xrs.2788

By:

Furukawa, Hiroaki;
Ichimaru, Naoto;
Suzuki, Keijiro;
Nishino, Makoto;
Broughton, Jennifer;
Leinders, Johan;
Ochi, Hirotomo

Publication type:

Article

Utility of Biomarker‐Informed Drug Interaction Evaluation in Drug Development and Regulatory Decision Making.

Published in:

Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 2, p. 398, doi. 10.1002/cpt.3436

By:

Ishiguro, Akihiro;
Kusuhara, Hiroyuki;
Kimoto, Emi;
Miyoshi, So;
Mizuno, Katsuhiko;
Hoshino, Motohiro;
Suzuki, Hiroshi

Publication type:

Article

Adaptive randomization for balancing over covariates.

Published in:

WIREs: Computational Statistics, 2014, v. 6, n. 4, p. 288, doi. 10.1002/wics.1309

By:

Hu, Feifang;
Hu, Yanqing;
Ma, Zhenjun;
Rosenberger, William F.

Publication type:

Article

A Comparison of Methods for Thorough QT Analysis for the Assessment of Cardiac Safety.

Published in:

Pharmaceutical Medicine, 2016, v. 30, n. 1, p. 15, doi. 10.1007/s40290-015-0123-5

By:

Ferber, Georg;
Johannesen, Lars

Publication type:

Article

Evaluation of Analytical Quality by Design Approaches on the Development and Optimization of Size Exclusion Chromatography Analytical Procedures for Bovine Serum Albumin.

Published in:

Journal of Separation Science, 2025, v. 48, n. 5, p. 1, doi. 10.1002/jssc.70168

By:

Gaggero, Alessio;
Jeremic, Dalibor;
Sattler, Reingard;
Paudel, Amrit;
Afonso Urich, Jesús Alberto

Publication type:

Article

Simultaneous Determination of 10 Fat‐Soluble Vitamins by Ultra‐Performance Liquid Chromatography in Multivitamins With Minerals Capsules.

Published in:

Journal of Separation Science, 2025, v. 48, n. 5, p. 1, doi. 10.1002/jssc.70167

By:

Jeelani, Salika;
Kassymbek, Zarema

Publication type:

Article

An effective and sensitive stability-indicating chromatographic approach based on HPLC for silodosin assay.

Published in:

Journal of Analytical Science & Technology, 2016, v. 7, n. 1, p. 1, doi. 10.1186/s40543-016-0100-y

By:

Er, Engin;
Erk, Nevin

Publication type:

Article

Effects of Sugammadex Doses up to 32mg/kg Alone or in Combination with Rocuronium or Vecuronium on QTc Prolongation: AThorough QTc Study.

Published in:

Clinical Drug Investigation, 2010, v. 30, n. 9, p. 599, doi. 10.2165/11537210-000000000-00000

By:

de Kam, Pieter-Jan;
van Kuijk, Jacqueline;
Prohn, Marita;
Thomsen, Torben;
Peeters, Pierre

Publication type:

Article

Simultaneous Determination of Nirmatrelvir and Ritonavir in Bulk and Tablet Dosage Form by RP-HPLC Method.

Published in:

International Journal of Pharmaceutical Investigation, 2025, v. 15, n. 3, p. 1039, doi. 10.5530/ijpi.20250328

By:

Gawali, Rohit;
Godge, Rahul Keshav;
Dhamak, Kavita;
Patel, Arshu

Publication type:

Article

Mutagenicity in a Molecule: Identification of Core Structural Features of Mutagenicity Using a Scaffold Analysis.

Published in:

PLoS ONE, 2016, v. 11, n. 2, p. 1, doi. 10.1371/journal.pone.0148900

By:

Hsu, Kuo-Hsiang;
Su, Bo-Han;
Tu, Yi-Shu;
Lin, Olivia A.;
Tseng, Yufeng J.

Publication type:

Article

Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence.

Published in:

British Journal of Clinical Pharmacology, 2025, v. 91, n. 2, p. 310, doi. 10.1111/bcp.16347

By:

Lynggaard, Helle;
McKendrick, Sue;
Baird, Mark;
Kerwash, Essam;
Lanius, Vivian;
Lasch, Florian;
Wright, David

Publication type:

Article

Replacing the thorough QT study: reflections of a baby in the bath water.

Published in:

British Journal of Clinical Pharmacology, 2014, v. 78, n. 2, p. 195, doi. 10.1111/bcp.12296

By:

Kleiman, Robert B.;
Shah, Rashmi R.;
Morganroth, Joel

Publication type:

Article

A Validated New Gradient Stability-Indicating LC Method for the Analysis of Doripenem in Bulk and Injection Formulation.

Published in:

Chromatography Research International, 2013, p. 1, doi. 10.1155/2013/963595

By:

Kathirvel, Singaram;
Devalarao, Garikapati

Publication type:

Article

A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Pyridoxine Hydrochloride and Meclizine Hydrochloride in Pharmaceutical Solid Dosage Forms.

Published in:

Chromatography Research International, 2013, p. 1, doi. 10.1155/2013/747060

By:

Nawaz, Md. Saddam

Publication type:

Article

Method Development and Validation of High Performance Liquid Chromatography Method for Methylparaben and Butylparaben in Ointment Form.

Published in:

Journal of Biochemical Technology, 2019, v. 10, n. 1, p. 33, doi. 10.51847/jx6l73r

By:

Manoharan, Gunasekar;
Mohamed, Ramadan Abdel Wahed

Publication type:

Article

Formulation and Evaluation of pH-Responsive Mini-Tablets for Ileo-Colonic Targeted Drug Delivery.

Published in:

Tropical Journal of Pharmaceutical Research, 2014, v. 13, n. 7, p. 1021, doi. 10.4314/tjpr.v13i7.3

By:

Hadi, Mohd Abdul;
Rao, N. G. Raghavendra;
Rao, A. Srinivasa

Publication type:

Article

Simultaneous Determination of Psychoactive Compounds in Foodstuffs Using Micellar Liquid Chromatography with Direct Injection.

Published in:

Journal of AOAC International, 2014, v. 97, n. 2, p. 409, doi. 10.5740/jaoacint.12-350

By:

SUBHRA, HOONKA;
PRAKASH, DUBEY-NEETI;
ABHILASHA, DURGBANSHI;
JOSEP, ESTEVE-ROMERO;
DEVASISH, BOSE

Publication type:

Article

Bucket List.

Published in:

Quality Progress, 2014, v. 47, n. 1, p. 64

By:

SUEDBECK, JOHN G.

Publication type:

Article

A simple, sensitive and rapid isocratic reversed-phase high-performance liquid chromatography method for determination and stability study of curcumin in pharmaceutical samples.

Published in:

Avicenna Journal of Phytomedicine, 2017, v. 7, n. 5, p. 444

By:

Amanolahi, Farjad;
Mohammadi, Ali;
Oskuee, Reza Kazemi;
Nassirli, Hooriyeh;
Malaekeh-Nikouei, Bizhan

Publication type:

Article

Stress degradation studies on Telmisartan and development of a validated method by UV spectrophotometry in bulk and pharmaceutical dosage forms.

Published in:

Pharmaceutical Methods, 2011, v. 2, n. 4, p. 253, doi. 10.4103/2229-4708.93396

By:

Patel, Komal;
Dhudasia, Komal;
Patel, Amit;
Dave, Jayant;
Patel, Chaganbhai

Publication type:

Article

A Quantitative Method for Weight Selection in SGDDP.

Published in:

Journal of Biopharmaceutical Statistics, 2015, v. 25, n. 6, p. 1179, doi. 10.1080/10543406.2014.971171

By:

Huang, Qin;
Chen, Gang;
Yuan, Zhilong;
Zhang, Ying;
Wenrich, Judy

Publication type:

Article

Statistical Properties of the Design for Simultaneous Global Drug Development Program.

Published in:

Journal of Biopharmaceutical Statistics, 2015, v. 25, n. 6, p. 1135, doi. 10.1080/10543406.2014.971166

By:

Liu, Kezhen;
Yuan, Zhilong;
Chen, Gang;
Huang, Qin;
Wenrich, Judith

Publication type:

Article

Stress Degradation Assessment of Lamotrigine Using a Validated Stability-Indicating HPTLC Method.

Published in:

Journal of Chemistry, 2013, p. 1, doi. 10.1155/2013/608196

By:

Michail, Karim;
Daabees, Hoda M.;
Beltagy, Youssef;
Abdel-Khalek, Magdi;
Khamis, Mona M.

Publication type:

Article

ICH E14 Q & A ( R1) document: perspectives on the updated recommendations on thorough QT studies.

Published in:

British Journal of Clinical Pharmacology, 2013, v. 75, n. 4, p. 959, doi. 10.1111/j.1365-2125.2012.04442.x

By:

Shah, Rashmi R.;
Morganroth, Joel

Publication type:

Article

Stability Indicating High Performance Liquid Chromatography Method Development, Validation, and Characterization of Forced Degradant Product by Liquid Chromatography–Mass Spectroscopy for Molnupiravir and Favipiravir.

Published in:

Journal of Chromatographic Science, 2025, v. 63, n. 4, p. 1, doi. 10.1093/chromsci/bmaf015

By:

Pethani, Trupesh M;
Sangani, Monika;
Santoki, Param S

Publication type:

Article

Identification and Structure Elucidation of Forced Degradation Products of the Novel Propionic acid Derivative Loxoprofen: Development of Stability-Indicating Chromatographic Methods Validated as per ICH Guidelines.

Published in:

Journal of Chromatographic Science, 2017, v. 55, n. 4, p. 417, doi. 10.1093/chromsci/bmw196

By:

Eissa, Maya S.;
Abd El-Sattar, Osama I.

Publication type:

Article

Development and Validation of a Gas Chromatography Method for Quality Control of Residual Solvents in Azilsartan Bulk Drugs.

Published in:

Journal of Chromatographic Science, 2017, v. 55, n. 4, p. 393, doi. 10.1093/chromsci/bmw192

By:

Jin Guan;
Jie Min;
Feng Yan;
Wen-Ya Xu;
Shuang Shi;
Si-Lin Wang

Publication type:

Article

Stability-Indicating HPLC Method for Arteether and Application to Nanoparticles of Arteether.

Published in:

Journal of Chromatographic Science, 2014, v. 52, n. 8, p. 831, doi. 10.1093/chromsci/bmt125

By:

Gugulothu, Dalapathi;
Patravale, Vandana

Publication type:

Article

A Versatile Liquid Chromatographic Technique for Pharmacokinetic Estimation of Curcumin in Human Plasma.

Published in:

Journal of Chromatographic Science, 2014, v. 52, n. 8, p. 872, doi. 10.1093/chromsci/bmt131

By:

Gugulothu, Dalapathi;
Desai, Preshita;
Patravale, Vandana

Publication type:

Article

International Vision and Strategy for Drug Regulatory Authority: The PMDA's International Vision.

Published in:

Clinical Pharmacology & Therapeutics, 2012, v. 92, n. 3, p. 349, doi. 10.1038/clpt.2012.90

By:

Tominaga, Toshiyoshi;
Ando, Yuki;
Kondo, Tatsuya

Publication type:

Article

Standard Comparison: Assessing risk management processes for regulated health industries.

Published in:

Quality Progress, 2017, v. 50, n. 6, p. 30

By:

Wright, Carolyn

Publication type:

Article

Regulatory Writing.

Published in:

Medical Writing, 2012, v. 21, n. 4, p. 317, doi. 10.1179/2047480612Z.00000000077

By:

Morley, Greg

Publication type:

Article

Historical Reflections on GCP.

Published in:

Applied Clinical Trials, 2017, v. 26, n. 6, p. 32

By:

Korteweg, Marijke

Publication type:

Article

Quality control of drug products: implementation of the new ICH Q3D guideline on elemental impurities.

Published in:

Macedonian Pharmaceutical Bulletin / Makedonsko Farmacevtski Bilten, 2016, v. 62, p. 127

By:

Lecornet, Gregory

Publication type:

Article

Developing a clinical trial governance framework for pharmaceutical industry-funded clinical trials.

Published in:

Accountability in Research: Policies & Quality Assurance, 2018, v. 25, n. 7/8, p. 373, doi. 10.1080/08989621.2018.1527222

By:

Nair, Satish Chandrasekhar;
AlGhafli, Shamsa;
AlJaberi, Ayesha

Publication type:

Article

Development and Validation of an HPTLC Method for Estimation of Coronarin D in Hedychium coronarium rhizome.

Published in:

Acta Chromatographica, 2017, v. 29, n. 3, p. 415, doi. 10.1556/1326.2017.29.3.11

By:

RAY, ASIT;
DASH, BISWABHUSAN;
SAHOO, SUPRAVA;
SAHOO, AMBIKA;
JENA, SUDIPTA;
KAR, BASUDEBA;
CHATTERJEE, TUHIN;
GHOSH, BISWAJIT;
NAYAK, SANGHAMITRA

Publication type:

Article

Development and Validation of a Reversed-Phase HPLC Method for Simultaneous Determination of Doxazosin Mesylate and Finasteride.

Published in:

Acta Chromatographica, 2017, v. 29, n. 3, p. 309, doi. 10.1556/1326.2017.29.3.01

By:

KROTZ, DILLON;
MENGESHA, ABEBE E.

Publication type:

Article