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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Drug Discovery

SOP for Evaluation of Anti-Inflammatory Properties in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for evaluating the anti-inflammatory properties of drug candidates in preclinical animal models. Anti-inflammatory testing is crucial to assess the potential of drug candidates to reduce or modulate inflammatory responses associated with diseases such as arthritis, asthma, or other chronic inflammatory conditions. This SOP ensures standardized methods for assessing anti-inflammatory efficacy, providing consistent and reproducible data that support the clinical development of therapeutic agents.
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Drug Discovery

SOP for Neurotoxicity Screening in Animal Models

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The purpose of this Standard Operating Procedure (SOP) is to define the methodology for conducting neurotoxicity screening in preclinical animal models. Neurotoxicity testing is essential for evaluating the potential effects of drug candidates or chemicals on the nervous system, which may lead to motor dysfunction, cognitive impairments, or behavioral changes. This SOP ensures that neurotoxicity studies are performed consistently, accurately, and in compliance with regulatory standards, providing critical safety data for clinical development.
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Drug Discovery

SOP for Allergenicity Testing in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for conducting allergenicity testing in preclinical studies. Allergenicity testing is essential for evaluating the potential of drug candidates or other substances to cause allergic reactions, including skin sensitization and respiratory hypersensitivity. This SOP ensures that allergenicity studies are performed consistently, accurately, and in compliance with regulatory standards, providing data to assess the safety of compounds and their potential to induce allergic reactions in humans.
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Drug Discovery

SOP for Immunotoxicity Testing in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for performing immunotoxicity testing in preclinical studies. Immunotoxicity testing is essential for assessing the potential effects of drug candidates on the immune system, which may lead to adverse effects such as immunosuppression, allergic reactions, or autoimmunity. This SOP ensures that immunotoxicity studies are performed in compliance with regulatory standards and that results are obtained with high consistency and reproducibility.
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Drug Discovery

SOP for Biochemical Analysis in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to outline the methodology for conducting biochemical analysis in preclinical studies. Biochemical analysis is essential for evaluating the effects of drug candidates on various biochemical markers, enzymes, metabolites, and other molecular targets. This SOP ensures that biochemical analyses are performed consistently, accurately, and in compliance with regulatory standards, providing valuable insights into the therapeutic potential or toxicity of a compound.
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Drug Discovery

SOP for Hematological Analysis in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting hematological analysis in preclinical studies. Hematological analysis is crucial in evaluating the effects of drug candidates on blood parameters, including red and white blood cells, hemoglobin levels, platelet count, and other markers. This SOP ensures that hematological tests are conducted consistently and in compliance with regulatory standards, providing reliable data for assessing the safety and efficacy of potential therapeutic agents.
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Drug Discovery

SOP for Preparing Tissue Samples for Histopathological Analysis

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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for preparing tissue samples for histopathological analysis. Histopathological analysis is essential for evaluating the effects of drug candidates, treatments, or disease processes on tissues and organs. This SOP ensures standardized methods for tissue collection, fixation, embedding, sectioning, and staining to obtain high-quality slides suitable for microscopic evaluation.
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Drug Discovery

SOP for Conducting Ex Vivo Studies in Preclinical Models

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The purpose of this Standard Operating Procedure (SOP) is to define the guidelines and methodology for conducting ex vivo studies using preclinical models. Ex vivo studies play a critical role in evaluating the effects of drug candidates on isolated tissues or organs outside of the living organism. This SOP ensures that the procedures are standardized to obtain reliable, reproducible results while maintaining the ethical treatment of animals and ensuring compliance with regulatory standards.
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Drug Discovery

SOP for Handling Laboratory Animals in Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to define the proper handling, care, and ethical treatment of laboratory animals used in preclinical studies. The SOP ensures that animals are handled in a humane, safe, and scientifically appropriate manner during all stages of the study, from transport and housing to experimental procedures. This SOP supports the maintenance of animal welfare and compliance with ethical guidelines and regulatory requirements.
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Drug Discovery

SOP for Managing Animal Facilities for Preclinical Studies

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The purpose of this Standard Operating Procedure (SOP) is to define the guidelines for the management and operation of animal facilities used in preclinical studies. This includes ensuring that animal welfare is maintained, regulatory standards are met, and proper care is given to animals used in studies. The management of these facilities plays a key role in supporting high-quality and reproducible preclinical research by maintaining appropriate housing, environmental conditions, and ethical standards.
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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
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  • BA-BE Studies V 2.0
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  • Creams V 2.0
  • Ointments V 2.0
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