pharmaceutical-expert

pharmaceutical-expert is a skill for Claude Code from personamanagmentlayer/pcl. It costs 80 tokens per session (1,365 once invoked), scanned A, original, Apache-2.0.

A pharmaceutical development and regulation guide covering clinical trials, drug safety, FDA processes, and Good Practice standards. Good Practice standards are documented rules for safely developing and monitoring medicines.

In plain words
What is it for?
It helps with clinical-trial work, drug-development planning, safety monitoring, and regulatory submissions.
Why use it?
It gives developers context for work that must meet drug-industry regulations and record-keeping requirements.

Skill for Claude Code

Written for Claude Code: allowed-tools in frontmatter.

Good fit It helps with clinical-trial work, drug-development planning, safety monitoring, and regulatory submissions.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/personamanagmentlayer/pcl/pharmaceutical-expert
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add personamanagmentlayer/pcl --skill pharmaceutical-expert
Clone the repo
git clone --depth 1 https://github.com/personamanagmentlayer/pcl

Made for: Claude Code.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for pharmaceutical-expert

README.md
[![agentmods](https://agentmods.dev/badge/skills/personamanagmentlayer/pcl/pharmaceutical-expert/github.svg)](https://agentmods.dev/skills/personamanagmentlayer/pcl/pharmaceutical-expert)
Your own site
<a href="https://agentmods.dev/skills/personamanagmentlayer/pcl/pharmaceutical-expert"><img src="https://agentmods.dev/badge/skills/personamanagmentlayer/pcl/pharmaceutical-expert/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for pharmaceutical-expert

Your own site · 80×15
<a href="https://agentmods.dev/skills/personamanagmentlayer/pcl/pharmaceutical-expert"><img src="https://agentmods.dev/badge/skills/personamanagmentlayer/pcl/pharmaceutical-expert.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 80 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 1,365 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe. Third-party audits
  • NVIDIA SkillSpector pass 7 Sept 2026
How audits are shown
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00080 $0.01365
Opus 5 $0.00040 $0.00682
Sonnet 5 $0.00016 $0.00273
Haiku 4.5 $0.00008 $0.00136

Measured 5d ago against content hash c835d4001aad, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-10, from the pricing page.

Security

Grade A, and why

pharmaceutical-expert scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 5d ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

stdlib/domains/pharmaceutical-expert/SKILL.md · 184 lines

How it starts

The opening of the file, as written. The whole thing — 184 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Pharmaceutical Expert

You are an expert in pharmaceutical development, clinical trials management, FDA compliance, Good Practice (GxP) standards, pharmacovigilance, and regulatory submissions. You understand the complete drug development lifecycle from discovery through post-market surveillance.

Core Pharmaceutical Concepts

Drug Development Lifecycle

Phases of Development:

  • Discovery & Preclinical: Target identification, lead optimization, in vitro/in vivo studies
  • Phase I: Safety and dosing in healthy volunteers (20-100 subjects)
  • Phase II: Efficacy and side effects in patients (100-300 subjects)
  • Phase III: Confirmatory trials in larger patient populations (300-3000+ subjects)
  • FDA Review: NDA/BLA submission and regulatory review
  • Phase IV: Post-marketing surveillance and additional studies

Regulatory Pathways:

  • Standard NDA (New Drug Application)
  • Fast Track designation for serious conditions
  • Breakthrough Therapy for substantial improvement
  • Accelerated Approval for unmet medical needs
  • Priority Review (6 months vs. 10 months)
  • Orphan Drug designation for rare diseases

GxP Standards

Good Practice Standards:

  • GCP (Good Clinical Practice): Clinical trial conduct and monitoring
  • GLP (Good Laboratory Practice): Preclinical laboratory studies
  • GMP (Good Manufacturing Practice): Drug manufacturing and quality control
  • GDP (Good Distribution Practice): Supply chain and distribution
  • GVP (Good Pharmacovigilance Practice): Safety monitoring and reporting

Clinical Trial Management

Trial Design Elements:

  • Protocol development and amendments
  • Informed consent process (ICF)
  • Inclusion/exclusion criteria
  • Randomization and blinding strategies
  • Endpoints (primary, secondary, exploratory)
  • Statistical analysis plans (SAP)
  • Data Safety Monitoring Board (DSMB)

Trial Monitoring:

  • Site initiation visits (SIV)
  • Monitoring visits and source data verification (SDV)
  • Audit and inspection readiness
  • Deviation and protocol violation management
  • Adverse event reporting (SAE, SUSAR)

Read the full file on GitHub · 184 lines

Files

What ships with it

1 file beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 5d ago First seen · 184 lines · 80 tokens per session scan A c835d4001aad

Subscribe to this mod's changes

pharmaceutical-expert is a skill published in the GitHub repository personamanagmentlayer/pcl (40 stars, last pushed 3d ago), licensed Apache-2.0. It adds 80 tokens to every session and 1,365 once invoked, about $0.0004 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-05.

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