Tag: SOP for Clinical Data Management

SOP for Documentation of Formulation Screening Processes

SOP for Documentation of Formulation Screening Processes Standard Operating Procedure (SOP) for Documentation of Formulation Screening Processes 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting the formulation screening activities in the development of pharmaceutical products. Formulation screening is a critical step in identifying the optimal formulation…

Drug Discovery

SOP for Preparation of Drug-Excipient Interaction Reports

SOP for Preparation of Drug-Excipient Interaction Reports Standard Operating Procedure (SOP) for Preparation of Drug-Excipient Interaction Reports 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing drug-excipient interaction reports. Drug-excipient interactions are crucial factors to consider during the development of pharmaceutical formulations, as they can significantly influence…

Drug Discovery

SOP for High-Performance Liquid Chromatography (HPLC) in Formulation Testing

SOP for High-Performance Liquid Chromatography (HPLC) in Formulation Testing Standard Operating Procedure (SOP) for High-Performance Liquid Chromatography (HPLC) in Formulation Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the use of High-Performance Liquid Chromatography (HPLC) in the testing of pharmaceutical formulations. HPLC is a critical analytical technique…

Drug Discovery

SOP for In-Vitro Testing of Formulations for Efficacy

SOP for In-Vitro Testing of Formulations for Efficacy Standard Operating Procedure (SOP) for In-Vitro Testing of Formulations for Efficacy 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting in-vitro testing of pharmaceutical formulations to assess their efficacy. In-vitro testing is a critical step in the development of…

Drug Discovery

SOP for Scale-Up of Prototype Formulations

SOP for Scale-Up of Prototype Formulations Standard Operating Procedure (SOP) for Scale-Up of Prototype Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for scaling up prototype formulations from laboratory or pilot scale to larger commercial batch sizes. The scale-up process is critical to ensuring that the formulation…

Drug Discovery

SOP for Preparation of Formulation Development Reports

SOP for Preparation of Formulation Development Reports Standard Operating Procedure (SOP) for Preparation of Formulation Development Reports 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing formulation development reports for pharmaceutical formulations. The formulation development report is a critical document that summarizes the formulation design, process development,…

Drug Discovery

SOP for Conducting Pilot Stability Studies of Formulations

SOP for Conducting Pilot Stability Studies of Formulations Standard Operating Procedure (SOP) for Conducting Pilot Stability Studies of Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting pilot stability studies of pharmaceutical formulations. Pilot stability studies are essential to assess the impact of storage conditions on…

Drug Discovery

SOP for Assessing Storage Conditions for Formulation Stability

SOP for Assessing Storage Conditions for Formulation Stability Standard Operating Procedure (SOP) for Assessing Storage Conditions for Formulation Stability 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for assessing storage conditions that ensure the stability of pharmaceutical formulations. Stability is a critical quality attribute of a drug product,…

Drug Discovery

SOP for Screening Hydrogels for Drug Delivery Applications

SOP for Screening Hydrogels for Drug Delivery Applications Standard Operating Procedure (SOP) for Screening Hydrogels for Drug Delivery Applications 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for screening hydrogels for drug delivery applications. Hydrogels are three-dimensional, cross-linked networks of hydrophilic polymers that can hold large amounts of…

Drug Discovery

SOP for Incorporation of APIs in Nanoemulsion Formulations

SOP for Incorporation of APIs in Nanoemulsion Formulations Standard Operating Procedure (SOP) for Incorporation of APIs in Nanoemulsion Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for incorporating active pharmaceutical ingredients (APIs) into nanoemulsion formulations. Nanoemulsions are colloidal systems consisting of fine droplets (typically less than 100…

Drug Discovery