Guidance Documents

HBV: Drug Development

Status: Draft

Organization: FDA

Early Alzheimer’s Disease: Drug Development

Status: Draft

Organization: FDA

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

Status: Draft

Organization: FDA

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

Status: Final

Organization: FDA

Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products

Status: Draft

Organization: FDA

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Status: Draft

Organization: FDA

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

Status: Draft

Organization: FDA

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

Status: Final

Organization: FDA

S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals

Status: Draft

Organization: FDA

S9 Guideline: S9 Implementation Working Group: Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers

Status: Draft

Organization: ICH

Elemental Impurities in Drug Products

Status: Final

Organization: FDA

Bioanalytical Method Validation

Status: Final

Organization: FDA

Guidance Documents

Enter Keyword

Topic/Sub-Topic

HBV: Drug Development

Early Alzheimer’s Disease: Drug Development

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals

S9 Guideline: S9 Implementation Working Group: Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers

Elemental Impurities in Drug Products

Bioanalytical Method Validation

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

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Guidance Documents

Enter Keyword

Topic/Sub-Topic

HBV: Drug Development

Early Alzheimer’s Disease: Drug Development

Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals

S9 Guideline: S9 Implementation Working Group: Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers

Elemental Impurities in Drug Products

Bioanalytical Method Validation

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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