Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals [[electronic resource] /] / by John Geigert |
| Autore | Geigert John |
| Edizione | [4th ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (597 pages) |
| Disciplina | 615/.19 |
| Soggetto topico |
Biologicals
Biopharmaceutics Pharmaceutical chemistry Pharmacy Biologics Pharmaceutics |
| ISBN | 3-031-31909-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities. |
| Record Nr. | UNINA-9910731488803321 |
Geigert John
|
||
| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Meta-analysis in Clinical Research: Principles and Procedures [[electronic resource] /] / by Anoop Kumar
| Meta-analysis in Clinical Research: Principles and Procedures [[electronic resource] /] / by Anoop Kumar |
| Autore | Kumar Anoop |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (129 pages) |
| Disciplina | 610.72 |
| Soggetto topico |
Pharmacology
Medical sciences Drug development Biologicals Biopharmaceutics Preclinical Research Biologics |
| ISBN | 981-9923-70-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1_Introduction -- Chapter2_Systematic literature review (SLR) -- Chapter 3_Registration and software’s -- Chapter 4_Quality Assessment of Studies -- Chapter 5_Extraction and Analysis of data -- Chapter 6_Models in Meta-analysis -- Chapter 7_Heterogeneity and Publications bias -- Chapter 8_Sensitivity and subgroup analysis -- Chapter 9_Meta-regression -- Chapter 10_Plots in Meta-analysis -- Chapter 11_Network Meta-analysis -- Chapter 12_Common mistakes -- Chapter 13_Challenges -- Chapter 14_Future Perspectives -- Chapter 15_Future perspectives. |
| Record Nr. | UNINA-9910739468403321 |
|
Kumar Anoop
|
||
| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical Biotechnology [[electronic resource] ] : Fundamentals and Applications / / edited by Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm
| Pharmaceutical Biotechnology [[electronic resource] ] : Fundamentals and Applications / / edited by Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm |
| Edizione | [6th ed. 2024.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2024 |
| Descrizione fisica | 1 online resource (XXV, 682 p. 259 illus., 245 illus. in color.) |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical chemistry
Biotechnology Pharmacology Medicine - Research Biology - Research Drug delivery systems Biologicals Biopharmaceutics Pharmaceutics Biomedical Research Drug Delivery Biologics |
| ISBN | 3-031-30023-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Molecular Biotechnology -- Biophysical and biochemical analysis of recombinant proteins -- Production and downstream processing of biotech products -- Formulation of biotech products, including biopharmaceutical considerations -- Pharmacokinetics and pharmacodynamics of peptide and protein drugs -- Immunogenicity of pharmaceutical proteins -- General considerations of monoclonal antibodies from structure to therapeutic application -- Genomics, Other “Omics” Technologies, Personalized Medicine and Additional Biotechnology-Related Techniques -- Dispensing biotechnology products: handling, professional education and product information -- Economic considerations in medical biotechnology -- Regulatory framework for biosimilars -- Vaccines -- Oligonucleotides and siRNA -- Gene therapy -- Stem cell technology -- Therapeutic Applications.-Endocrinology -- Insulin -- Follicle-stimulating hormone -- Growth hormone -- Cardiovascular and Respiratory Applications -- Recombinant coagulation factors and thrombolytics -- Recombinant human deoxyribonuclease -- Oncology -- Monoclonal antibodies in oncology -- Hematopoetic growth factors -- Inflammation and Immunemodulation -- Monoclonal antibodies in transplantation -- Monoclonal antibodies and antibody-based therapeutics in anti-inflammatory therapy -- Interferons and interleukins -- Anti-infectious diseases -- Monoclonal antibodies -- Enzyme replacement therapy. |
| Record Nr. | UNINA-9910806198603321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2024 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines [[electronic resource] /] / edited by Jenny Lam, Philip Chi Lip Kwok
| Respiratory Delivery of Biologics, Nucleic Acids, and Vaccines [[electronic resource] /] / edited by Jenny Lam, Philip Chi Lip Kwok |
| Autore | Lam Jenny |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (224 pages) |
| Disciplina | 615.19 |
| Altri autori (Persone) | KwokPhilip Chi Lip |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmaceutical chemistry
Drug delivery systems Biologicals Biopharmaceutics Vaccines - Biotechnology Biomaterials Drugs - Design Pharmacology Drug Delivery Systems Chemistry, Pharmaceutical Drug Design Pharmaceutics Drug Delivery Biologics Biomaterials-Vaccines Structure-Based Drug Design |
| ISBN | 3-031-47567-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Chapter 1: Design strategies of dry powders for pulmonary delivery of pharmaceutical peptides -- Chapter 2. Pulmonary delivery of antibody for the treatment of respiratory diseases -- Chapter 3: Dry powder formulation of monoclonal antibodies for pulmonary delivery -- Chapter 4: Antimicrobial peptides and proteins for inhalation -- Chapter 5: Pulmonary delivery of nucleic acids -- Chapter 6: Intranasal and inhaled vaccines -- Chapter 7: Respiratory delivery of probiotics to improve lung health -- Chapter 8: Respiratory delivery of bacteriophages for the treatment of lung infections -- Chapter 9: Pharmacokinetics of inhaled medications – what do we know about biological macromolecules?. |
| Record Nr. | UNINA-9910805576803321 |
|
Lam Jenny
|
||
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
- Biologicals (4)
-
Biologics
(4)
- Biopharmaceutics (4)
- Pharmaceutical chemistry (3)
- Pharmaceutics (3)