Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and StabilityCRC Press, 3 Okt 2018 - 580 halaman "Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples." |
Isi
| 1 | |
Assay Development | 25 |
Assay Validation | 71 |
Scaleup Design and Analysis | 119 |
USP Tests and Specifications | 151 |
Process Validation | 199 |
Quality Assurance | 235 |
Stability Studies | 271 |
Design for LongTerm Stability Studies | 329 |
Stability Analysis with Fixed Batches | 359 |
Stability Analysis with Random Batches | 391 |
Statistical Tables | 435 |
SAS Programs | 469 |
Regulations | 475 |
| 549 | |
| 557 | |
Edisi yang lain - Lihat semua
Statistical Design and Analysis in Pharmaceutical Science: Validation ... Shein-Chung Chow,Jen-pei Liu Pratinjau tidak tersedia - 1995 |
Statistical Design and Analysis in Pharmaceutical Science: Validation ... Shein-Chung Chow,Jen-Pei Liu Pratinjau tidak tersedia - 2019 |
Istilah dan frasa umum
acceptance limits accuracy and precision active ingredient analysis ANOVA appropriate Arrhenius equation assay method assay results central composite design components confidence interval content uniformity testing control chart degradation line degrees of freedom determination dissolution distribution dosage form dosage units drug characteristics drug product drug product containers drug shelf drug substance effects error evaluate expiration dating period F distribution factors FDA guideline fractional factorial design given in Table in-process interaction intercept label claim least-squares level of significance manufacturing process matrix null hypothesis obtained package parameters pharmaceutical potency probability of passing random random effects model rejected release targets requirements sample mean sampling plan scaleup Shewhart slope stability data stability testing stage standard deviation statistical methods storage conditions strength studentized residuals sum of squares T₁ tablets temperature three batches upper quantile USP test USP/NF specifications validation variability variance variation X₁ Y₁ zero σ²