Bioanalytical Method Validation: Concepts, Expectations and Challenges in Small Molecule and Macromolecule—A Report of PITTCON 2013 Symposium Journal title: The AAPS Journal Authors: Edward D. Bashaw, Binodh DeSilva, Mark J. Rose, Yow-Ming C. Wang, Chinmay Shukla Subject(s): Medicine
Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team Journal title: The AAPS Journal Authors: R. J. Briggs, R. Nicholson, F. Vazvaei, J. Busch, M. Mabuchi, K. S. Mahesh, M. Brudny-Kloeppel, N. W... Subject(s): Medicine
Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments Journal title: The AAPS Journal Authors: Joseph C. Marini, Michael Anderson, Xiao-Yan Cai, John Chappell, Todd Coffey, Dominique Gouty, Aparn... Subject(s): Medicine
Retrospective Data Analysis and Proposal of a Practical Acceptance Criterion for Inter-laboratory Cross-validation of Bioanalytical Methods Using Liquid Chromatography/Tandem Mass Spectrometry Journal title: The AAPS Journal Authors: Tomoki Yoneyama, Takashi Kudo, Fumihiro Jinno, Eric R. Schmidt, Takahiro Kondo Subject(s): Medicine
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies Journal title: The AAPS Journal Authors: Helmut Schütz, Detlew Labes, Anders Fuglsang Subject(s): Medicine
Specific Method Validation and Sample Analysis Approaches for Biocomparability Studies of Denosumab Addressing Method and Manufacture Site Changes Journal title: The AAPS Journal Authors: Ramak Pourvasei, Ed Lee, Michael Eschenberg, Vimal Patel, Chris Macaraeg, Kinnari Pandya, Judy Shih,... Subject(s): Medicine
Validation of a Ligand Binding Assay Using Dried Blood Spot Sampling Journal title: The AAPS Journal Authors: Daniel Burns, Laura Brunner, Surendran Rajendran, Beth Johnson, Mark Ma, Jin Wang Subject(s): Medicine
A new equivalence based metric for predictive check to qualify mixed-effects models Journal title: The AAPS Journal Authors: Pravin R. Jadhav, Jogarao V. S. Gobburu Subject(s): Medicine
Selective and validated spectrophotometric methods for the determination of nicorandil in pharmaceutical formulations Journal title: The AAPS Journal Authors: Nafisur Rahman, Yasmin Ahmad, Syed Najmul Hejaz Azmi Subject(s): Medicine
Acceptance Probability (Pa) Analysis for Process Validation Lifecycle Stages Journal title: AAPS PharmSciTech Authors: Daniel Alsmeyer, Ajay Pazhayattil, Shu Chen, Francesco Munaretto, Maksuda Hye, Pradeep Sanghvi Subject(s): Medicine
Antitumor Activity of DMAKO-05, a Novel Shikonin Derivative, and Its Metabolism in Rat Liver Microsome Journal title: AAPS PharmSciTech Authors: Xu Zhang, Ru-Bing Wang, Wen Zhou, Sui Xiao, Qing-Qing Meng, Shao-Shun Li Subject(s): Medicine
Development and Validation of a Discriminative Dissolution Method for Atorvastatin Calcium Tablets using in vivo Data by LC and UV Methods Journal title: AAPS PharmSciTech Authors: J. C. Machado, A. D. Lange, V. Todeschini, N. M. Volpato Subject(s): Medicine
Review on Pharmaceutical Process Validation Journal title: Asian Pacific Journal of Nursing and Health Sciences Authors: Tenzin Wangpo1*, D.S Rathore2 , Yogendra Singh3 1Sun Rise University, Alwar, Rajasthan, India 2Pr... Subject(s): Medicine, Nursing, Health and Wellness
A Validated Reverse Phase-Ultra-Performance Liquid Chromatography Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation Journal title: Turkish Journal of Pharmaceutical Sciences Authors: Hebatallah A. WAGDY, Mohamed TAREK, Ahmed AMER, Menna GAMAL, Mohey ELMAZAR Subject(s): Medicine, Pharmacology
Investigation of the Presence of Sildenafil in Herbal Dietary Supplements by Validated HPLC Method Journal title: Turkish Journal of Pharmaceutical Sciences Authors: Emrah DURAL Subject(s): Medicine, Pharmacology
