| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
AAPS open social media strategy (2021–2025)
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Shah, Harsh S.
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1 |
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artikel
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| 2 |
AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016
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Freed, A. L.
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2017
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1 |
p. 1-10
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artikel
|
| 3 |
A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody
|
Patterson, Marilyn
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1 |
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artikel
|
| 4 |
Acceleration of new medicines–CMC lessons learned from emergency use authorizations
|
Bernstein, James
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1 |
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artikel
|
| 5 |
A competitive ligand-binding assay for the detection of neutralizing antibodies against dostarlimab (TSR-042)
|
Zhang, Xiaolong Tom
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|
|
|
1 |
|
artikel
|
| 6 |
Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD
|
Huynh-Ba, Kim
|
|
2017
|
|
1 |
p. 1-6
|
artikel
|
| 7 |
An industrial case study: QbD to accelerate time-to-market of a drug product
|
Testas, Madalena
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1 |
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artikel
|
| 8 |
Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection
|
Beaumont, Maribel
|
|
2018
|
|
1 |
p. 1-17
|
artikel
|
| 9 |
ANVISA: an introduction to a new regulatory agency with many challenges
|
Huynh-Ba, Kim
|
|
2018
|
|
1 |
p. 1-6
|
artikel
|
| 10 |
A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects
|
Tanguay, Mario
|
|
2018
|
|
1 |
p. 1-6
|
artikel
|
| 11 |
A review of in vivo and in vitro aspects of alcohol-induced dose dumping
|
D’Souza, Susan
|
|
2017
|
|
1 |
p. 1-20
|
artikel
|
| 12 |
A review on lipid-based nanocarriers mimicking chylomicron and their potential in drug delivery and targeting infectious and cancerous diseases
|
Elnady, Rana E.
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1 |
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artikel
|
| 13 |
A risk-based approach to validation of ion chromatography methods using suppressed conductivity
|
Nelson, Deanna J.
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1 |
|
artikel
|
| 14 |
Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia
|
Jani, Darshana
|
|
2018
|
|
1 |
p. 1-14
|
artikel
|
| 15 |
Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report
|
Mathews, Joel
|
|
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1 |
|
artikel
|
| 16 |
Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets
|
Yu, Alex
|
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1 |
|
artikel
|
| 17 |
CMC development of [14C]-labeled sotorasib for the conduct of microtracer human ADME study
|
Sharma, Sonika
|
|
|
|
1 |
|
artikel
|
| 18 |
Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis
|
Blaser, David A.
|
|
2017
|
|
1 |
p. 1-10
|
artikel
|
| 19 |
Compatibility study of patiromer with juices/liquids and soft foods
|
Khoeiklang, Martin
|
|
|
|
1 |
|
artikel
|
| 20 |
Considerations and recommendations on traditional and non-traditional uses of excipients in oral drug products
|
Constantinides, Panayiotis P.
|
|
2016
|
|
1 |
p. 1-6
|
artikel
|
| 21 |
Correction: Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM)
|
Kemper, Christopher
|
|
|
|
1 |
|
artikel
|
| 22 |
Customer-centric product presentations for monoclonal antibodies
|
Bittner, Beate
|
|
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1 |
|
artikel
|
| 23 |
Dawn of a new beginning
|
Allmendinger, Andrea
|
|
|
|
1 |
|
artikel
|
| 24 |
Designing an ideal alcohol-based hand sanitizer: in vitro antibacterial responses of ethanol and isopropyl alcohol solutions to changing composition
|
Nzekwe, Ifeanyi T.
|
|
|
|
1 |
|
artikel
|
| 25 |
Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC)
|
Chong, Sannie Siaw Foong
|
|
2018
|
|
1 |
p. 1-8
|
artikel
|
| 26 |
Development and evaluation of taste masked dry syrup formulation of potassium chloride
|
Kulkarni, Madhur
|
|
2019
|
|
1 |
p. 1-10
|
artikel
|
| 27 |
Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers
|
Abrigo, Nicolas
|
|
|
|
1 |
|
artikel
|
| 28 |
Development of an algorithm to identify mass production candidate molecules to develop children’s oral medicines: a North American perspective
|
Bhatt-Mehta, Varsha
|
|
2016
|
|
1 |
p. 1-8
|
artikel
|
| 29 |
Development of human-machine language interfaces for the visual analysis of complex biologics and RNA modalities and associated experimental data
|
Kunz, Roxanne K.
|
|
|
|
1 |
|
artikel
|
| 30 |
Dissolution profile evaluation of selected brands of amoxicillin-clavulanate potassium 625 mg tablets retailed in Hawassa town, Sidama Regional State, Ethiopia
|
Endashaw, Eyob
|
|
|
|
1 |
|
artikel
|
| 31 |
Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation
|
Ekeigwe, Abigail A.
|
|
2019
|
|
1 |
p. 1-15
|
artikel
|
| 32 |
Editorial for an official journal of the American association of pharmaceutical scientists
|
Riley, Christopher M.
|
|
2015
|
|
1 |
p. 1
|
artikel
|
| 33 |
Enhancement of material attributes of poorly compressible metformin hydrochloride through coprocessing with hydroxypropyl cellulose (HPC-L) using coprecipitation (CPT)
|
Chaturvedi, Kaushalendra
|
|
|
|
1 |
|
artikel
|
| 34 |
Erratum to: Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD
|
Hastedt, Jayne E.
|
|
2016
|
|
1 |
p. 1
|
artikel
|
| 35 |
Extraction of niclosamide from commercial approved tablets into aqueous buffered solution creates potentially approvable oral and nasal sprays against COVID-19 and other respiratory infections
|
Needham, David
|
|
|
|
1 |
|
artikel
|
| 36 |
FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary
|
Karara, Adel H.
|
|
2016
|
|
1 |
p. 1-3
|
artikel
|
| 37 |
Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study
|
Yuk, Inn H.
|
|
|
|
1 |
|
artikel
|
| 38 |
Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach
|
Shah, Harsh S.
|
|
|
|
1 |
|
artikel
|
| 39 |
Glycopeptide antibiotic drug stability in aqueous solution
|
Jakaria, Sardar M.
|
|
|
|
1 |
|
artikel
|
| 40 |
Heat pre-treatment can abolish anti-drug antibody interference in ligand binding pharmacokinetic assays
|
Poulsen, Svend
|
|
|
|
1 |
|
artikel
|
| 41 |
Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies
|
Stüber, Jakob C.
|
|
|
|
1 |
|
artikel
|
| 42 |
Improving the safety of disposable auto-injection devices: a systematic review of use errors
|
Weinhold, Thomas
|
|
2018
|
|
1 |
p. 1-14
|
artikel
|
| 43 |
Incorporating random effects in biopharmaceutical control strategies
|
Oberleitner, Thomas
|
|
|
|
1 |
|
artikel
|
| 44 |
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid
|
Algorri, Marquerita
|
|
|
|
1 |
|
artikel
|
| 45 |
Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment
|
Alasandro, Mark
|
|
|
|
1 |
|
artikel
|
| 46 |
Molecular docking assisted exploration on solubilization of poorly soluble drug remdesivir in sulfobutyl ether-tycyclodextrin
|
Zhang, Yumeng
|
|
|
|
1 |
|
artikel
|
| 47 |
Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma
|
Alharbi, Hanan M.
|
|
2018
|
|
1 |
p. 1-9
|
artikel
|
| 48 |
New directions in pharmaceutical amorphous materials and amorphous solid dispersions, a tribute to Professor George Zografi – Proceedings of the June 2016 Land O’Lakes Conference
|
Newman, Ann
|
|
2017
|
|
1 |
p. 1-14
|
artikel
|
| 49 |
Non-isothermal stability by linear heating: a fast method for preformulation stability screening of drugs at the discovery and development interface
|
Kairer, Agnes
|
|
2017
|
|
1 |
p. 1-14
|
artikel
|
| 50 |
Observation of antitumor mechanism of GE11-modified paclitaxel and curcumin liposomes based on cellular morphology changes
|
Tang, Hailing
|
|
|
|
1 |
|
artikel
|
| 51 |
Oral nanoemulsions of candesartan cilexetil: formulation, characterization and in vitro drug release studies
|
Ali, Halah Hussein
|
|
2017
|
|
1 |
p. 1-16
|
artikel
|
| 52 |
Oral solid self-nanoemulsifying drug delivery systems of candesartan citexetil: formulation, characterization and in vitro drug release studies
|
Ali, Halah Hussein
|
|
2017
|
|
1 |
p. 1-17
|
artikel
|
| 53 |
PEGylated magnetic nanographene oxide for targeted delivery of arsenic trioxide and sec-o-glucosylhamaudol in tumor treatment with improved dual-drugs synergistic effect
|
Cheng, Jinlai
|
|
|
|
1 |
|
artikel
|
| 54 |
Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study
|
Dong, Yongzhi
|
|
|
|
1 |
|
artikel
|
| 55 |
Pharmacokinetic and pharmacodynamic analyses of terlipressin in patients with hepatorenal syndrome
|
Wang, Xiaofeng
|
|
|
|
1 |
|
artikel
|
| 56 |
Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT)
|
Fujioka, Kazutoshi
|
|
|
|
1 |
|
artikel
|
| 57 |
Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies
|
Puppolo, Michael M.
|
|
2017
|
|
1 |
p. 1-13
|
artikel
|
| 58 |
PLGA-based nanoparticles for the treatment of cancer: current strategies and perspectives
|
Alvi, Maria
|
|
|
|
1 |
|
artikel
|
| 59 |
Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)
|
Li, Hanlin
|
|
2016
|
|
1 |
p. 1-9
|
artikel
|
| 60 |
Preparation, characterization, and biological activity of the inclusion complex of dihydroquercetin and β-Cyclodextrin
|
Xu, Yaping
|
|
|
|
1 |
|
artikel
|
| 61 |
Preparation of O/W nano-emulsion containing nettle and fenugreek extract and cumin essential oil for evaluating antidiabetic properties
|
Javadi, Sara
|
|
|
|
1 |
|
artikel
|
| 62 |
Relative bioavailability of diazoxide, manufactured at two different international locations, in healthy participants under fasting conditions: an open-label, two-stage, adaptive, sequential two-period crossover study
|
Behm, Martin Otto
|
|
2017
|
|
1 |
p. 1-9
|
artikel
|
| 63 |
Research on Pickering emulsification technology based on the concept of “combination of medicine and adjuvant” to improve the pH stability of volatile oil in solid preparations—taking Lingzhu Pulvis as an Example
|
Peng, Lei
|
|
|
|
1 |
|
artikel
|
| 64 |
Results from in vitro and in vivo studies evaluating the bioavailability, effects of food, and administration as crushed tablet suspension on vericiguat pharmacokinetics
|
Becker, Corina
|
|
|
|
1 |
|
artikel
|
| 65 |
Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL TM)
|
Kemper, Christopher
|
|
|
|
1 |
|
artikel
|
| 66 |
Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan
|
Shibata, Hiroko
|
|
2016
|
|
1 |
p. 1-11
|
artikel
|
| 67 |
Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD
|
Hastedt, Jayne E.
|
|
2016
|
|
1 |
p. 1-20
|
artikel
|
| 68 |
Self-microemulsifying system of an ethanolic extract of Heliopsis longipes root for enhanced solubility and release of affinin
|
Marrero-Morfa, Dailenys
|
|
|
|
1 |
|
artikel
|
| 69 |
Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches
|
Stangler, Thomas
|
|
2019
|
|
1 |
p. 1-6
|
artikel
|
| 70 |
Simple and rapid method for analysis of urinary vancomycin using solid phase extraction and fluorescence spectroscopy
|
Oshima, Yuki
|
|
|
|
1 |
|
artikel
|
| 71 |
Solid form changes during drug development: good, bad, and ugly case studies
|
Newman, Ann
|
|
2016
|
|
1 |
p. 1-11
|
artikel
|
| 72 |
Stability challenges not addressed by harmonized guidance – AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD
|
Khan, Mohd M.
|
|
2018
|
|
1 |
p. 1-7
|
artikel
|
| 73 |
Stability considerations for drug-device combination products-21 CFR part 4 update
|
Latoz, Christopher
|
|
|
|
1 |
|
artikel
|
| 74 |
Stability of levothyroxine tablets in blister packaging versus bottles and vials under simulated in-use conditions
|
Chun, Jonathan
|
|
|
|
1 |
|
artikel
|
| 75 |
Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0
|
Jakaria, Sardar M.
|
|
|
|
1 |
|
artikel
|
| 76 |
Structured content and data management—enhancing acceleration in drug development through efficiency in data exchange
|
Beierle, Jill
|
|
|
|
1 |
|
artikel
|
| 77 |
Substandard and falsified medicine screening technologies
|
Roth, Lukas
|
|
2019
|
|
1 |
p. 1-12
|
artikel
|
| 78 |
Technical transfer and commercialisation of lyophilised biopharmaceuticals — application of lyophiliser characterisation and comparability
|
Cullen, Sean
|
|
|
|
1 |
|
artikel
|
| 79 |
The degradation of poloxamer 188 in buffered formulation conditions
|
Chen, Wei
|
|
|
|
1 |
|
artikel
|
| 80 |
The journey to AAPS 2020: a reflection from strategic planning to PharmSci 360
|
Polli, Joseph W.
|
|
2018
|
|
1 |
p. 1-4
|
artikel
|
| 81 |
Therapeutic effects of dracocephalum heterophyllum in collagen-induced arthritis
|
Wang, Yalan
|
|
|
|
1 |
|
artikel
|
| 82 |
Transdermal drug delivery system of lidocaine hydrochloride based on dissolving gelatin/sodium carboxymethylcellulose microneedles
|
Bahmani, Shabnam
|
|
|
|
1 |
|
artikel
|
| 83 |
Tritium labeling of antisense oligonucleotides via different conjugation agents
|
Edelmann, Martin R.
|
|
|
|
1 |
|
artikel
|
| 84 |
Understanding the implication of Kawakita model parameters using in-die force-displacement curve analysis for compacted and non-compacted API powders
|
Rashid, Iyad
|
|
|
|
1 |
|
artikel
|
| 85 |
Utility of in vitro release testing (IVRT) to assess ‘sameness’ of 1% clotrimazole creams for use as a biowaiver
|
Wellington, Hannah
|
|
|
|
1 |
|
artikel
|
| 86 |
Utilization of risk-based predictive stability within regulatory submissions; industry’s experience
|
McMahon, Megan
|
|
|
|
1 |
|
artikel
|
| 87 |
Utilizing cross-product prior knowledge to rapidly de-risk chemical liabilities in therapeutic antibody candidates
|
Jacobitz, Alex W.
|
|
|
|
1 |
|
artikel
|
| 88 |
Verification of nanoparticle formation, skin permeation, and apoptosis using nobiletin as a methoxyflavonoid derivative
|
Inoue, Yutaka
|
|
|
|
1 |
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artikel
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