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Abbreviation : ICH
Long Form : International Conference on Harmonization
No. Year Title Co-occurring Abbreviation
2020 Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally. EMA, FDA, LMICs, WHO
2020 Conventional and first derivative synchronous spectrofluorimetric methods for the simultaneous determination of cisatracurium and nalbuphine in biological fluids. ---
2020 Development and validation of a reversed-phase high performance liquid chromatographic method for the quantitation and stability of alpha-Lipoic acid in cosmetic creams. LOD, LOQ
2020 Development of improved QSAR models for predicting the outcome of the in vivo micronucleus genetic toxicity assay. ---
2020 Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times. EC
2020 Fluorescamine-based fluorophore for spectrofluorimetric determination of heptaminol in human plasma; application to spiked human plasma. ---
2020 Implementing a Globally Harmonized Risk Assessment-Based Approach for Regulatory Decision-Making of Crop Protection Products. ---
2020 Microphysiological heart-liver body-on-a-chip system with a skin mimic for evaluating topical drug delivery. ---
2020 Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS. DBS, PK, TK, VAMS
10  2020 Preclinical safety assessment of pathogen reduced red blood cells treated with amustaline and glutathione. FDA, PR, PR-RBCC
11  2020 Preparation and evaluation of anti-wrinkle cream containing saffron extract and avocado oil. GIAS
12  2020 Quantification of Alfacalcidol Tablets Dissolution Content by Chemical Derivatization and LC-MS. APCI, ESI, LC-MS, LOD, PTAD
13  2020 Selective quantitation of co-formulated ternary mixture in the presence of potential impurities by liquid chromatographic methods. ---
14  2020 Sensitive Inexpensive HPLC Determination of Novel Anticancer Combination in Nanoparticles and Rat Plasma: Pharmacokinetic Application. ATRA, FDA, GNS
15  2020 Suitability of Amoxicillin-Clavulanic Acid for Administration via Prolonged Infusion. ANCOVA, WFI
16  2020 Synthesis and characterization of oxitropium bromide related substances and novel stability indicating HPLC methods. ---
17  2020 The simultaneous quantification of phytosterols and tocopherols in liposomal formulations using validated atmospheric pressure chemical ionization- liquid chromatography -tandem mass spectrometry. APCI
18  2019 A Cell-Based Strategy for Bioactivity Determination of Long-Acting Fc-Fusion Recombinant Human Growth Hormone. GH, hGHR, LAGH, rhGH
19  2019 A clinical study for the evaluation of pharmacokinetic interaction between daclatasvir and fluoxetine. DCV, FLX, HCV, LOD
20  2019 A High-Demanding Strategy to Ensure the Highest Quality Standards of Oral Liquid Individualized Medicines for Pediatric Use. SOPs
21  2019 A High-Performance Liquid Chromatographic Method for the Determination of Meropenem in Serum. MEM
22  2019 A validated HPTLC method for the simultaneous quantifications of three phenolic acids and three withanolides from Withania somnifera plants and its herbal products. HPTLC, LOD, LOQ
23  2019 Adverse drug reactions of Yunnan Baiyao capsule: a multi-center intensive monitoring study in China. ADRs, AEs, APS, YBC
24  2019 Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug-Related Deaths. ---
25  2019 Application of HPTLC, spectrofluorimetry and differential pulse voltammetry for determination of the antifungal drug posaconazole in suspension dosage form. HMDE, HPTLC, PSZ
26  2019 Applications of Fourier transform infrared spectroscopic method for simultaneous quantitation of some hypoglycemic drugs in their binary mixtures. FTIR, GLIM, LODs, Metf, PIOG, VILD
27  2019 Assessing the ratio of means as a causal estimand in clinical endpoint bioequivalence studies in the presence of intercurrent events. DOM, PP, RoM, SACE
28  2019 Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative. CiPA
29  2019 Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay. rhKGF1, SRE
30  2019 Biological Safety Studies and Simultaneous Determination of Linagliptin and Synthetic Impurities by LC-PDA. LGT
31  2019 Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally. EMA, FDA, LMICs, WHO
32  2019 Challenges and insights of early oncology drug development in the Asia-Pacific region: introduction of phase I oncology clinical trial center and experience sharing for early clinical trials in Seoul National University Hospital, Korea. CTA, PD, PK, SNUBH CTC, SNUH CTC
33  2019 Control Strategy Approach for a Well-Characterized Vaccine Drug Product. FHbps
34  2019 Determination of Cholesterol and its Derivatives in Nanoliposomes as Drug Delivery Conveyances by HPLC-UV: A Simple, Accurate and Cost-Effective Method Development and Validation Approach. HPLC, MoChol, UV
35  2019 Determination of Ondansetron by Spectrofluorimetry: Application to Forced Degradation Study, Pharmaceuticals and Human Plasma. OND
36  2019 Development and Validation of A Fast, Simple And Specific Stability Indicating RP-HPLC Method for Determination of Dexpanthenol in Eye Gel Formulation. ---
37  2019 Development and validation of a new HPLC analytical method for the determination of diclofenac in tablets. DS, HPLC, IS, LOD, LOQ
38  2019 Development and validation of a stability-Indicating RP-HPLC method for simultaneous estimation of sofosbuvir and velpatasvir in fixed dose combination tablets and plasma. LOD, LOQ, RP-HPLC, RSD, SOF, VLP
39  2019 Development and Validation of HPLC Fluorescence and UPLC/DAD Stability-Indicating Methods for Determination of Hepatitis C Antiviral Agent Daclatasvir. UPLC
40  2019 Development of a new liquid chromatographic method for the simultaneous separation of ciprofloxacin degradation products with 5-hydroxymethyl-furfural, impurity of D-glucose, in an intravenous solution for perfusion. 5-HMF
41  2019 Development of a new stability indicating method for the simultaneous separation of voriconazole from its impurities along with sodium benzoate used as a preservative in a powder for oral suspension. ---
42  2019 Development of a validated method for the qualitative and quantitative analysis of cannabinoids in plant biomass and medicinal cannabis resin extracts obtained by super-critical fluid extraction. FDA, LOD, LOQ, SFE, TGA, UHPLC-DAD
43  2019 Dissolution or disintegration - substitution of dissolution by disintegration testing for a fixed dose combination product. ---
44  2019 Enantiomeric separation of ivabradine by cyclodextrin-electrokinetic chromatography. Effect of amino acid chiral ionic liquids. CDs, CILs, EKC, LODs
45  2019 Enantioselective Box Behenken Optimized HPLC-DAD Method for the Simultaneous Estimation of Alogliptin Enantiomorphs in Pharmaceutical Formulations and their Pharmacokinetic Study in Rat Plasma. ALO
46  2019 Enantioseparation of N-acetyl-dl-cysteine as o-phtaldialdehyde derivatives obtained with various primary aliphatic amine additives on polysaccharide-based chiral stationary phases. HPLC
47  2019 Evaluation of physicochemical properties and bacterial photoinactivation of phenothiazine photosensitizers. LOD, LOQ, RSD
48  2019 Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study. CI, di-HCl, PPI
49  2019 First derivative synchronous spectrofluorimetric method for the simultaneous determination of propofol and cisatracurium besylate in biological fluids. ---
50  2019 Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma. HPTLC, IMP A, IMP B, PR
51  2019 Highly sensitive spectrofluorimetric method for rapid determination of orciprenaline in biological fluids and pharmaceuticals. ORP
52  2019 Identification, isolation and characterization of dolutegravir forced degradation products and their cytotoxicity potential. ---
53  2019 Impact of Phase 1 study design on estimation of QT interval prolongation risk using exposure-response analysis. C-QT, DeltaQT, LME
54  2019 Improvement of quantitative structure-activity relationship (QSAR) tools for predicting Ames mutagenicity: outcomes of the Ames/QSAR International Challenge Project. DGM/NIHS, QSAR
55  2019 International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products. ---
56  2019 Introduction to in silico model for proarrhythmic risk assessment under the CiPA initiative. CiPA, hERG, TdP
57  2019 Liquid Chromatographic Method Development for Quantification of Inorganic Nitrite and Nitrate Impurities from Nitroglycerin Drug Substance by Using Ion-Pair Reagents with Liquid-Liquid Extraction Technique. LC
58  2019 Medicinal products for geriatric patients in Germany : Current status of regulatory requirements and clinical reality. EMA, GIP, PIP, SmPC
59  2019 Method development for simultaneous determination of active ingredients in cough and cold pharmaceuticals by high performance liquid chromatography. USP
60  2019 Micellar-based spectrofluorimetric method for the selective determination of ledipasvir in the presence of sofosbuvir: application to dosage forms and human plasma. ---
61  2019 Possibility of extending biopharmaceutics classification system based biowaiver to BCS class IIa drug. BCS, FDA, IR, WHO
62  2019 Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses. ---
63  2019 Proposed reduction of the in vivo pyrogen test by the in vitro LAL assay for the quality control of anticrotallic, antiscorpion, antirabies and antitetanus sera. FDA
64  2019 Prospects for using a new sequential chemiluminescence strategy for monitoring the caffeine content in soft and energy drinks via the catalytic activities of different nano-metal oxides. CAF, NPs, SIA-CL
65  2019 Rapid fluorescent focus inhibition test optimization and validation: Improved detection of neutralizing antibodies to rabies virus. DEAE, GCLP, RFFIT, RVNA, SRIGs, WHO
66  2019 Regulatory Trends in Drug Development in Asia Pacific. AP
67  2019 Second-derivative synchronous spectrofluorimetric assay of dapagliflozin: Application to stability study and pharmaceutical preparation. DGF
68  2019 Simple and Accurate HPTLC-Densitometric Method for Assay of Nandrolone Decanoate in Pharmaceutical Formulation. HPTLC, Rf
69  2019 Simultaneous Determination of Co-administrated Deflazacort, Aprepitant and Granisetron in Dosage Forms and Spiked Human Plasma by RP-HPLC/PAD. ---
70  2019 Simultaneous Determination of Moxifloxacin and Flavoxate by RP-HPLC and Ecofriendly Derivative Spectrophotometry Methods in Formulations. FLX, MOX, RP
71  2019 Simultaneous determination of piroxicam and norfloxacin in biological fluids by high-performance liquid chromatography with fluorescence detection at zero-order emission mode. HPLC-FLD, NRF, PRX
72  2019 Spectrofluorimetric determination of eptifibatide in human plasma and dosage form. ---
73  2019 Spectrofluorimetric investigation with green analytical procedures for estimation of bambuterol and terbutaline: Application to pharmaceutical dosage forms and content uniformity testing. BAM, TER, USP
74  2019 Stability of Meropenem After Reconstitution for Administration by Prolonged Infusion. HPLC, MIC, NMR
75  2019 Study of degradation behavior of besifloxacin, characterization of its degradation products by LC-ESI-QTOF-MS and their in silico toxicity prediction. DPs
76  2019 Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses. AT, GC
77  2019 Validated Liquid Chromatographic Method for the Determination of (Canagliflozin, Dapagliflozin or Empagliflozin) and Metformin in the Presence of (1-Cyanoguanidine). LC
78  2019 [Impurity profile of macitentan in tablet dosage form using a stability-indicating high performance liquid chromatography method and forced degradation study]. MAC, PAH
79  2019 [Quality control of mixtures for pediatric parenteral nutrition: Validation of sodium and potassium assay method]. MPN
80  2018 A Brief Introduction to Antibody-Drug Conjugates for Toxicologic Pathologists. ADCs
81  2018 A Capillary Zone Electrophoresis Method with Multiresponse Chemometric Optimization for the Simultaneous Determination of Zofenopril Calcium and Hydrochlorothiazide in Presence of Hydrochlorothiazide Major Impurities. CCD, CT, CZE, GAM, HCT, RSM, ZOF
82  2018 A comparative study of sterically and electro-statically stabilized silver nanoparticles for the determination of muscle relaxant tizanidine: Insights of localized surface plasmon resonance, surface enhanced Raman spectroscopy and electrocatalytic activity. EIS, SERS
83  2018 Alkaline degradation of lyophilized DMSA prior to labeling with 99mTc: Identification and development of the degradation pathway by HPLC and MS. DMSA, DP, DTGA, ESI
84  2018 An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment. ---
85  2018 Application of quinone-based fluorophore and native fluorescence for the spectrofluorimetric determination of agomelatine in dosage form: Identification of acidic and alkaline- induced degradation products by LC-MS/TOF. AGM, CD, DDQ, RFI, TCNQ
86  2018 Comprehensive Assessment of Degradation Behavior of Simvastatin by UHPLC/MS Method, Employing Experimental Design Methodology. ---
87  2018 Construction and application of (Q)SAR models to predict chemical-induced in vitro chromosome aberrations. CHL, CHO
88  2018 Current strategies in the non-clinical safety assessment of biologics: New targets, new molecules, new challenges. FIH, MABEL, mRNA, NHPs
89  2018 Determination of S-Allylmercaptocysteine in Rat Plasma by LC-MS/MS and its Application to a Pharmacokinetics Study. SAMC
90  2018 Determination of the Marker Diarylheptanoid Phytoestrogens in Curcuma comosa Rhizomes and Selected Herbal Medicinal Products by HPLC-DAD. DAD, LOD, LOQ, RSD
91  2018 Development and validation of a (RP)UHPLC-UV-(HESI/Orbitrap)MS method for the identification and quantification of mixtures of intact therapeutical monoclonal antibodies using a monolithic column. BEV, CTX, FDA, INF, mAbs, RP, RTX, TTZ, USP
92  2018 Development and validation of HPTLC fingerprints of three species of Alpinia with biomarker Galangin. HPTLC
93  2018 Development and validation of ultra-performance liquid chromatography method for the determination of meloxicam and its impurities in active pharmaceutical ingredients. UPLC
94  2018 Development of a chromatographic method with multi-criteria decision making design for simultaneous determination of nifedipine and atenolol in content uniformity testing. ATN, FLD, HPLC, IS, MCDM, NFD
95  2018 Development of a highly sensitive high-performance thin-layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations. ---
96  2018 Development of a HILIC method for the determination of 5-fluorouracil from nano drug delivery systems and rat skin extracts. 5-FU, DAD, HILIC, NLC, SLN
97  2018 Development of a stability- indicating HPLC method for simultaneous determination of ten related substances in vonoprazan fumarate drug substance. LC, LOD, LOQ
98  2018 Development of a validated HPLC method for the quantitative determination of trelagliptin succinate and its related substances in pharmaceutical dosage forms. DM, HPLC, LOD, LOQ
99  2018 Earth-friendly spectrophotometric methods for simultaneous determination of ledipasvir and sofosbuvir: Application to average content and uniformity of dosage unit testing. BP, DW, ISP, LED, SOF
100  2018 Fluorimetric determination of febuxostat in dosage forms and in real human plasma via Forster resonance energy transfer. FBX, FRET