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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: SOP for Clinical Data Management

SOP for Preparing Preclinical Study Protocols

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SOP for Preparing Preclinical Study Protocols Standard Operating Procedure (SOP) for Preparing Preclinical Study Protocols 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide a standardized approach for preparing preclinical study protocols. Preclinical study protocols ensure that all aspects of the study, such as design, animal welfare, regulatory compliance, and safety…

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Drug Discovery

SOP for Conducting Animal Studies for Preclinical Safety

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SOP for Conducting Animal Studies for Preclinical Safety Standard Operating Procedure (SOP) for Conducting Animal Studies for Preclinical Safety 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting animal studies for preclinical safety assessments of drug candidates. Animal studies are critical to assess the safety of new…

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Drug Discovery

SOP for Metabolic Stability Testing

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SOP for Metabolic Stability Testing Standard Operating Procedure (SOP) for Metabolic Stability Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting metabolic stability testing of drug candidates in preclinical models. Metabolic stability studies are crucial for understanding the drug’s potential for metabolism in the liver and…

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Drug Discovery

SOP for Tissue Distribution Studies in Preclinical Testing

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SOP for Tissue Distribution Studies in Preclinical Testing Standard Operating Procedure (SOP) for Tissue Distribution Studies in Preclinical Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting tissue distribution studies during preclinical testing. Tissue distribution studies are essential for understanding the distribution of a drug candidate…

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Drug Discovery

SOP for Pharmacokinetic Studies in Preclinical Models

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SOP for Pharmacokinetic Studies in Preclinical Models Standard Operating Procedure (SOP) for Pharmacokinetic Studies in Preclinical Models 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting pharmacokinetic (PK) studies in preclinical models. Pharmacokinetics is the study of the absorption, distribution, metabolism, and excretion (ADME) of a drug…

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Drug Discovery

SOP for Conducting Reproductive Toxicology Studies

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SOP for Conducting Reproductive Toxicology Studies Standard Operating Procedure (SOP) for Conducting Reproductive Toxicology Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting reproductive toxicology studies to evaluate the potential effects of a drug candidate on fertility, reproductive health, and offspring development. Reproductive toxicity testing is…

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Drug Discovery

SOP for Genotoxicity Testing Using Ames Test

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SOP for Genotoxicity Testing Using Ames Test Standard Operating Procedure (SOP) for Genotoxicity Testing Using Ames Test 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting genotoxicity testing using the Ames test in drug discovery research. The Ames test is a widely used in vitro assay for…

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Drug Discovery

SOP for Chronic Toxicity Studies in Preclinical Testing

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SOP for Chronic Toxicity Studies in Preclinical Testing Standard Operating Procedure (SOP) for Chronic Toxicity Studies in Preclinical Testing 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting chronic toxicity studies in animals during preclinical testing. Chronic toxicity studies are designed to evaluate the long-term effects of…

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Drug Discovery

SOP for Acute Toxicity Testing in Animals

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SOP for Acute Toxicity Testing in Animals Standard Operating Procedure (SOP) for Acute Toxicity Testing in Animals 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting acute toxicity testing in animals during the preclinical phase of drug discovery. Acute toxicity testing is essential for evaluating the potential…

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Drug Discovery

SOP for In Vitro Toxicity Screening

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SOP for In Vitro Toxicity Screening Standard Operating Procedure (SOP) for In Vitro Toxicity Screening 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting in vitro toxicity screening of drug candidates during the preclinical phase of drug discovery. In vitro toxicity screening is essential for identifying potential…

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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
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Capsules V 2.0
  • Creams 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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