ISPE

OCTOBER 27, 2022

Towards Next Generation Antisense Oligonucleotides: Mesylphosphoramidate Modification Improves Therapeutic Index and Duration of Effect of Gapmer Antisense Oligonucleotides.” 16 (20 September 2021): 9026–41. “Oligonucleotide Therapeutics: From Discovery and Development to Patentability.” Pharmaceutics 14, no. 2 (February 2022): 260.

Process Improvement 98

Process Improvement Packaging Compounding Dosage 98

ISPE

MARCH 29, 2023

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3 CPP 3 IPC Film coat weight gain (P.3.4)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3 CPP 3 IPC Film coat weight gain (P.3.4)

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. 1 (2021):7200. 13 July 2021. The fit-for-purpose and reduced-size POD units promote green manufacturing. 3 a b c Algorri, M., Madhyastha.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.

Documentation 52

Documentation FDA Packaging Communication 52