scholarly journals The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

2021 ◽  
pp. 2000297
Author(s):  
Peter Hoogevest ◽  
Harry Tiemessen ◽  
Josbert M. Metselaar ◽  
Simon Drescher ◽  
Alfred Fahr
Keyword(s):  
Line Extensions ◽  
Pharmaceutical Form

Development of tablets, as a pharmaceutical form, from comprimata to compressi – note II

Farmacist ro ◽  
2019 ◽  
Vol 3 (188) ◽  
pp. 38
Author(s):  
Alexandra Bujor ◽  
Mousa Sha’at ◽  
Andreea Crețeanu ◽  
Monica Creţan Stamate ◽  
Lăcrămioara Ochiuz
Keyword(s):  
Pharmaceutical Form

Alternativas farmacéuticas: ¿pueden ser intercambiables?

2020 ◽  
Vol 2 (2) ◽  
pp. 38-42
Author(s):  
Miriam del Carmen Carrasco-Portugal ◽  
Francisco Javier Flores-Murrieta
Keyword(s):  
Generic Substitution ◽  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Reference Formulation ◽  
Active Moiety ◽  
Significant Difference ◽  
Pharmaceutical Form ◽  
Extent Of Absorption

Pharmaceutical alternatives are products with the same active moiety, but different salt, ester or pharmaceutical form. Regulatory agencies have different criteria for this kind of drug. The European Medicines Agency (EMA) accepts the generic substitution using these alternatives, whereas the Food and Drug Administration (FDA) only authorizes generic substitution of pharmaceutical equivalents. The objective of this paper is to describe some relevant aspects that should be considered before deciding on making a generic substitution with pharmaceutical alternatives. It is important to note that a pharmaceutical alternative must show no significant difference in the rate and extent of absorption (bioequivalence) in a well-conducted in vivo study when compared with the reference formulation. Current Mexican regulations state that generic substitution is possible using pharmaceutical alternatives when bioequivalence is demonstrated in in vivo studies conducted under the NOM-177-SSA1-2013 criteria. In conclusion, generic substitution with pharmaceutical alternatives is possible if these products demonstrate in vivo bioequivalence when compared with the reference product.

Product Line Extensions: Analysis, Insights, and Intuition

2011 ◽  
Author(s):  
Liying Mu ◽  
Milind Dawande ◽  
Srinagesh Gavirneni ◽  
Chelliah Srishkandarajah
Keyword(s):  
Product Line ◽  
Line Extensions

scholarly journals Available options for doing more with less: laboraory automation as one tool in the arsenal

1998 ◽  
Vol 20 (3) ◽  
pp. 87-89
Author(s):  
Stephen Scypinski ◽  
John Baiano ◽  
Theodore Sadlowski
Keyword(s):  
Laboratory Automation ◽  
Drug Discovery Process ◽  
Contract Research Organization ◽  
Advantages And Disadvantages ◽  
Line Extensions ◽  
Use Of Resources ◽  
Analytical Development ◽  
Effective Use ◽  
Case Basis

Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.

Choice of pharmaceutical form as a key factor during ketogenic diet: a case report

2021 ◽  
pp. ejhpharm-2021-002727
Author(s):  
Héctor Rodríguez-Ramallo ◽  
Nerea Báez-Gutiérrez ◽  
Justo Valverde Fernandez ◽  
Francisco José Araujo-Rodríguez
Keyword(s):  
Case Report ◽  
Ketogenic Diet ◽  
Key Factor ◽  
Pharmaceutical Form

scholarly journals Profile of medicines used via oral and gastrointestinal catheter in a Walk-in Service

2018 ◽  
Vol 52 (0) ◽  
Author(s):  
Moara Avila de Jesus Moreira ◽  
Paula Pereira de Figueiredo ◽  
Rosemary Silva da Silveira ◽  
Valdecir Zavarese da Costa ◽  
Eliana Cardia de Pinho ◽  
...  
Keyword(s):  
Medical Records ◽  
Drug Class ◽  
Cross Sectional Study ◽  
Oral Route ◽  
Descriptive Statistics ◽  
University Hospital ◽  
Care Practice ◽  
Sectional Study ◽  
Cross Sectional ◽  
Pharmaceutical Form

ABSTRACT Objective: To identify the profile of drugs prescribed via oral and gastrointestinal catheter in a Walk-in Service of a University Hospital. Method: Quantitative cross-sectional study in which data were collected from the medical records of hospitalized patients using medication via oral or gastrointestinal catheter at least once a day between April and October 2015. The analysis was performed through descriptive statistics. Results: Out of 568 prescriptions (total), there were 143 different medications. The pharmaceutical form with the greatest number of prescriptions was solid (95.8%), of which 46.1% were simple tablets. The oral route had the highest number of administrations (97.3%). The most prescribed drug class was of anti-infectives (25.9%), but the Omeprazole drug was the most prescribed in the study (40%). Conclusion: There are indications that enable rethinking the care practice and establishing criteria and norms for contributing to the safety and efficacy of services provided in healthcare, especially regarding the preparation and administration of medications via gastrointestinal catheter.

Sign in / Sign up

Export Citation Format

Share Document