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Contemporary Biostatistics with Biopharmaceutical Applications / / edited by Lanju Zhang, Ding-Geng (Din) Chen, Hongmei Jiang, Gang Li, Hui Quan
| Contemporary Biostatistics with Biopharmaceutical Applications / / edited by Lanju Zhang, Ding-Geng (Din) Chen, Hongmei Jiang, Gang Li, Hui Quan |
| Edizione | [1st ed. 2019.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
| Descrizione fisica | 1 online resource (339 pages) |
| Disciplina |
610.727
519.5 |
| Collana | ICSA Book Series in Statistics |
| Soggetto topico |
Statistics
Biostatistics Pharmaceutical technology Statistics for Life Sciences, Medicine, Health Sciences Statistical Theory and Methods Pharmaceutical Sciences/Technology |
| ISBN | 3-030-15310-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I Biostatistical Methodology -- Dimension Reduction in High Dimensional Multivariate Time Series Analysis -- Multi-Panel Kendall Plot Applied to Measuring Dependence -- Flexible Optimal Design Strategies -- A Multivariate Spatial Modelling Approach with Nonparametric Cross-covariogram -- A Deterministic Global Optimization Method for Variational Inference -- Part II Statistical Genetics and Bioinformatics -- Subgroup identification with latent Dirichlet allocation -- Dictionary learning based genotype imputation to improve power for association testing -- Integrating Transcriptional Time Lag Information into Gene Regulatory Network Construction -- Optimal experimental designs for fMRI when the model matrix is uncertain -- On Exact and Approximate Distributions of K-homopolymer for iid and Markov Dependent DNA Sequences -- Part III Regulatory Statistics -- Utilizing Seamless Adaptive Designs for NASH Clinical Trials -- A Bayesian Non-inferiority Design with Companion Constancy Test in Active Controlled Trials -- A Study Design for Utilizing External Data to Augment the Control in a Randomized Controlled Trial -- Some thoughts in designing a Bayesian study: From a statistical reviewer’s perspective -- On Weighted Performance Goals in Medical Device Single-Arm Clinical Studies -- Part IV Biopharmaceutical Research and Applications.-Current Status Data in the Presence of a Terminal Event -- Seamless Phase 2/3 Study Design with an Oncology Example -- A Bayesian meta-analysis method for estimating risk difference of rare events -- Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials -- A Calibrated Power Prior Approach to Borrow Information from Historical Data with Application -- A Gatekeeping Test in a Group Sequential Design with Multiple Interim Looks -- Application of Bayesian Methods in Oncology Dose Escalation Studies with Late Onset Toxicity -- Bayesian hierarchical model estimation and comparison of immunogenicity assay cut-points.-Inference for Two-Stage Dynamic Treatment Regimes in the Presence of Drop -- Comparison of different approaches for dynamic prediction of survival using longitudinal data -- Update on progress of ASA Biopharm Safety Monitoring Working Group -- Options for implementing pattern-mixture-based sensitivity analyses. |
| Record Nr. | UNINA-9910349323603321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Nonclinical Statistics for Pharmaceutical and Biotechnology Industries / / edited by Lanju Zhang
| Nonclinical Statistics for Pharmaceutical and Biotechnology Industries / / edited by Lanju Zhang |
| Edizione | [1st ed. 2016.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2016 |
| Descrizione fisica | 1 online resource (705 p.) |
| Disciplina | 615.1 |
| Collana | Statistics for Biology and Health |
| Soggetto topico |
Statistics
Medicine Pharmacology Statistics for Life Sciences, Medicine, Health Sciences Medicine/Public Health, general Pharmacology/Toxicology |
| ISBN | 3-319-23558-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life.- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies. |
| Record Nr. | UNINA-9910254086203321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry / / by Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
| Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry / / by Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang |
| Autore | Burdick Richard K |
| Edizione | [1st ed. 2017.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 |
| Descrizione fisica | 1 online resource (XI, 379 p. 113 illus., 80 illus. in color.) |
| Disciplina | 615.1 |
| Collana | Statistics for Biology and Health |
| Soggetto topico |
Statistics
Pharmaceutical technology Pharmacy Statistics for Life Sciences, Medicine, Health Sciences Pharmaceutical Sciences/Technology |
| ISBN | 3-319-50186-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1. Introduction -- Chapter 2. Statistical Methods for CMC Applications -- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance -- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance -- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance -- Chapter 6. Analytical Procedures -- Chapter 7. Specifications -- Chapter 8. Stability -- Chapter 9. Analytical Comparability and Similarity. |
| Record Nr. | UNINA-9910165151003321 |
Burdick Richard K
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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