Guidance Documents

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Status: Draft

Organization: FDA

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling: Questions and Answers

Status: Draft

Organization: FDA

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment

Status: Final

Organization: FDA

Drug Products, Including Biological Products, that Contain Nanomaterials

Status: Draft

Organization: FDA

Draft Guidance on Doxorubicin Hydrochloride

Status: Draft

Organization: FDA

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Questions and Answers

Status: Draft

Organization: ICH

Safety Testing of Drug Metabolites

Status: Final

Organization: FDA

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Status: Final

Organization: FDA

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

Status: Draft

Organization: FDA

Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmakinetics and Bioavailability; and Labeling Documentation

Status: Draft

Organization: FDA

Analytical Procedures and Methods Validation for Drugs and Biologics

Status: Final

Organization: FDA

Expedited Programs for Serious Conditions – Drugs and Biologics

Status: Final

Organization: FDA

Guidance Documents

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Topic/Sub-Topic

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling: Questions and Answers

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment

Drug Products, Including Biological Products, that Contain Nanomaterials

Draft Guidance on Doxorubicin Hydrochloride

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Questions and Answers

Safety Testing of Drug Metabolites

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmakinetics and Bioavailability; and Labeling Documentation

Analytical Procedures and Methods Validation for Drugs and Biologics

Expedited Programs for Serious Conditions – Drugs and Biologics

Time is of the essence in Drug Development.

Contact the QPS Business Development Team Today!

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Join the QPS team and be part of our growing organization.

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Guidance Documents

Enter Keyword

Topic/Sub-Topic

Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling: Questions and Answers

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment

Drug Products, Including Biological Products, that Contain Nanomaterials

Draft Guidance on Doxorubicin Hydrochloride

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Questions and Answers

Safety Testing of Drug Metabolites

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmakinetics and Bioavailability; and Labeling Documentation

Analytical Procedures and Methods Validation for Drugs and Biologics

Expedited Programs for Serious Conditions – Drugs and Biologics

Time is of the essence in Drug Development.

Contact the QPS Business Development Team Today!

Your link to a rewarding career.

Join the QPS team and be part of our growing organization.

About qps

Preclinical Services

Clinical Services

Resources

Headquarters Location

Connect with us

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