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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: SOP for Drug Delivery Systems

SOP for Preclinical Study Report Preparation

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SOP for Preclinical Study Report Preparation Standard Operating Procedure (SOP) for Preclinical Study Report Preparation 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for preparing preclinical study reports. This SOP ensures that study reports are accurately and comprehensively prepared, following the data analysis and interpretation of preclinical studies….

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Drug Discovery

SOP for Ethical Review and Approval of Preclinical Studies

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SOP for Ethical Review and Approval of Preclinical Studies Standard Operating Procedure (SOP) for Ethical Review and Approval of Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for the ethical review and approval of preclinical studies. This SOP ensures that all preclinical studies involving animals are…

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Drug Discovery

SOP for Managing and Archiving Preclinical Study Data

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SOP for Managing and Archiving Preclinical Study Data Standard Operating Procedure (SOP) for Managing and Archiving Preclinical Study Data 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedures for managing and archiving preclinical study data. Proper data management ensures that study data is accurate, complete, and accessible for future…

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Drug Discovery

SOP for Conducting Preclinical GLP Studies

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SOP for Conducting Preclinical GLP Studies Standard Operating Procedure (SOP) for Conducting Preclinical GLP Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting preclinical studies in compliance with Good Laboratory Practice (GLP). GLP is a set of principles that ensures the quality, integrity, and reproducibility of…

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Drug Discovery

SOP for Bioanalytical Sample Analysis and Reporting

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SOP for Bioanalytical Sample Analysis and Reporting Standard Operating Procedure (SOP) for Bioanalytical Sample Analysis and Reporting 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for bioanalytical sample analysis and the subsequent reporting of results. This process is critical in ensuring that the data generated from bioanalytical testing…

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Drug Discovery

SOP for Preparing Bioanalytical Methods for Preclinical Studies

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SOP for Preparing Bioanalytical Methods for Preclinical Studies Standard Operating Procedure (SOP) for Preparing Bioanalytical Methods for Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for preparing bioanalytical methods used to quantify and analyze the concentration of drug candidates and their metabolites in biological samples during…

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Drug Discovery

SOP for Cardiotoxicity Testing Using Preclinical Models

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SOP for Cardiotoxicity Testing Using Preclinical Models Standard Operating Procedure (SOP) for Cardiotoxicity Testing Using Preclinical Models 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting cardiotoxicity testing in preclinical animal models. Cardiotoxicity testing is essential for assessing the potential adverse effects of drug candidates on the…

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Drug Discovery

SOP for Evaluating Drug-Drug Interactions in Preclinical Models

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SOP for Evaluating Drug-Drug Interactions in Preclinical Models Standard Operating Procedure (SOP) for Evaluating Drug-Drug Interactions in Preclinical Models 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for evaluating potential drug-drug interactions (DDIs) in preclinical models. Understanding DDIs is crucial to assess the safety, efficacy, and pharmacokinetic behavior…

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Drug Discovery

SOP for Establishing Dose-Response Curves in Preclinical Studies

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SOP for Establishing Dose-Response Curves in Preclinical Studies Standard Operating Procedure (SOP) for Establishing Dose-Response Curves in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the methodology for establishing dose-response curves in preclinical studies. Dose-response curves are essential in determining the relationship between the dose of a drug…

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Drug Discovery

SOP for Conducting Behavioral Studies in Animals

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SOP for Conducting Behavioral Studies in Animals Standard Operating Procedure (SOP) for Conducting Behavioral Studies in Animals 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting behavioral studies in animal models. Behavioral studies are essential in preclinical research to evaluate the impact of drug candidates or experimental…

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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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