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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: SOP for Lead Optimization

SOP for Solid Dispersion Screening Methods

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SOP for Solid Dispersion Screening Methods Standard Operating Procedure (SOP) for Solid Dispersion Screening Methods 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening solid dispersion methods in the formulation of drug candidates. Solid dispersions are a promising strategy to enhance the solubility and bioavailability of poorly…

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Drug Discovery

SOP for High-Throughput Formulation Screening Techniques

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SOP for High-Throughput Formulation Screening Techniques Standard Operating Procedure (SOP) for High-Throughput Formulation Screening Techniques 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for utilizing high-throughput formulation screening (HTFS) techniques in pharmaceutical formulation development. HTFS techniques are designed to rapidly evaluate and optimize multiple formulation parameters simultaneously, significantly…

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Drug Discovery

SOP for Use of Design of Experiments (DoE) in Formulation Screening

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SOP for Use of Design of Experiments (DoE) in Formulation Screening Standard Operating Procedure (SOP) for Use of Design of Experiments (DoE) in Formulation Screening 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for applying the Design of Experiments (DoE) methodology in formulation screening. DoE is a structured…

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Drug Discovery

SOP for Compatibility Studies Between API and Excipients

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SOP for Compatibility Studies Between API and Excipients Standard Operating Procedure (SOP) for Compatibility Studies Between API and Excipients 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting compatibility studies between Active Pharmaceutical Ingredients (APIs) and excipients used in drug formulations. Compatibility studies are crucial in ensuring…

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Drug Discovery

SOP for Preformulation Studies for Drug Candidates

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SOP for Preformulation Studies for Drug Candidates Standard Operating Procedure (SOP) for Preformulation Studies for Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting preformulation studies of drug candidates. Preformulation studies are essential in the early stages of drug development to assess the physicochemical properties…

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Drug Discovery

SOP for Screening Excipients for Formulation Development

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SOP for Screening Excipients for Formulation Development Standard Operating Procedure (SOP) for Screening Excipients for Formulation Development 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening excipients for formulation development. The selection of excipients is a critical step in the formulation of pharmaceutical products, influencing the stability,…

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Drug Discovery

SOP for pH-Solubility Profiling of Drug Candidates

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SOP for pH-Solubility Profiling of Drug Candidates Standard Operating Procedure (SOP) for pH-Solubility Profiling of Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting pH-solubility profiling of drug candidates. pH-solubility profiling is an essential step in preformulation studies, providing crucial information on the solubility of…

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Drug Discovery

SOP for Stability Testing of Screening Formulations

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SOP for Stability Testing of Screening Formulations Standard Operating Procedure (SOP) for Stability Testing of Screening Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for stability testing of screening formulations in pharmaceutical development. Stability testing is crucial for evaluating the shelf life, degradation profiles, and storage conditions…

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Drug Discovery

SOP for Solubility Testing of Drug Candidates

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SOP for Solubility Testing of Drug Candidates Standard Operating Procedure (SOP) for Solubility Testing of Drug Candidates 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for solubility testing of drug candidates. Solubility is a critical physicochemical property of pharmaceutical compounds, influencing their absorption, bioavailability, and overall effectiveness. This…

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Drug Discovery

SOP for Preparation of Screening Formulations

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SOP for Preparation of Screening Formulations Standard Operating Procedure (SOP) for Preparation of Screening Formulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing screening formulations in pharmaceutical development. Screening formulations are essential for evaluating the performance, stability, and efficacy of drug candidates during preclinical testing. This…

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Drug Discovery

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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